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Warning Letter 320-26-08

October 21, 2025

Dear Mr. McKibben:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Uriel Pharmacy, Inc., FEI 3003813327, at N8464 Sterman Rd., East Troy, from February 25 to March 4, 2025.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

In addition, the FDA reviewed the labeling evidence collected during the inspection of your facility and observed on your website www.shopuriel.com. Based on our review, all of your products labeled as homeopathic drug products that are offered for sale in the United States and packaged in glass ampule containers, including, “Aquilinum Taraxacum Homeopathic Ampules,” “Aurum 6X Homeopathic Ampules,” “Belladonna ex herba 6X Homeopathic Ampules,” “Gelsemium Bryonia Homeopathic Ampules,” “Nux vomica Chamomilla Homeopathic Ampules,” “Symphytum Stannum Homeopathic Ampules,” and “Viscum Mali e pl. tota 4X Homeopathic Ampules” (hereinafter your Homeopathic Ampule Drug products), are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

As described further below, these products also present significant public health concerns because your Homeopathic Ampule Drug products are packaged in glass ampules and could be mistaken for injectable drugs. Glass ampules are container closure systems typically used for sterile injectable drug products and may create confusion regarding the intended route of administration, potentially leading to serious harm if these unapproved new drugs are injected.

We reviewed your March 26, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

CGMP Violations

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)). Your firm also failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

You manufacture various drug products labeled as homeopathic including those intended for use on broken skin and scrapes, as well as drugs filled into glass ampules that are processed to be rendered sterile.

You failed to conduct adequate in-process and finished product testing of active ingredients to support the dilutions or processing to substantiate the potency claims stated on your products’ labels. For example, Calendula 10%, lot (b)(4), drug product is labeled to contain 50 gm of calendula in 100 gm at 1X, which is equivalent to approximately 5% concentration; and Arnica 20%, lot (b)(4), is labeled to contain 20 gm of arnica in 100 gm at 1X, which is equivalent to approximately 2% concentration of the respective active ingredients. However, you did not conduct in-process or finished product testing to verify that the stated strengths meet established in-process and finished product specifications.¹

Additionally, your Viscum Mali 50 drug product is labeled to contain 1X, 500 mg of Viscum Album (Mali), specifying the finished concentration in 1 gram is, “equivalent to 50 mg fresh plant.” This results in a finished drug product concentration of 5%. This concentration is large enough to be considered a measurable therapeutic dose and well within the current scientific capabilities for conducting assay testing on constituent chemicals within the labeled active ingredient. You failed to sample and test your drug product before release to ensure that the product was within its labeled specification, a violation of CGMP as well as a potential violation of other sections of 501 (e.g., subsections (b) and (c)) of the FD&C Act.

Manufacturing processes must consistently meet their parameters, and in-process materials must meet acceptance criteria or limits so that finished pharmaceutical products will meet their acceptance criteria.

Your response includes your procedure for (b)(4) techniques demonstrating your (b)(4). You state that “if further validation is necessary,” you need approximately (b)(4) days for method development and validation for (b)(4) intermediates. Your response is inadequate because you did not commit to developing methods or conducting validation.

As noted below, FDA is aware² that your viscum products are sometimes used as an injectable drug product where it is required to be sterile. You aseptically fill and process drugs such as Viscum Mali (and many other of your ampule drug products) through a (b)(4), using the same technology as sterile drug product manufacturers, but, as explained below, those processes are not adequate for aseptic manufacturing of a sterile injectable drug. You also conduct bacterial endotoxin and sterility testing before release, neither of which is generally required for oral medications.

Of note, FDA has documented that your processes are not adequate for aseptic manufacturing of a sterile injectable drug. For example, inappropriate cleaning methods were observed. The use of a (b)(4) mop was observed deviating from established cleaning patterns for the cleaning of your cleanroom walls. It was also observed that non-sterile cleaning and disinfecting agents were used in your cleanroom with inadequate contact times.

Your response states that you will update your procedures to clarify the proper cleaning method for cleaning walls, equipment, and surfaces to specify the requisite contact time for each disinfection agent used in the cleanroom, and that non-sterile cleaning agents were removed from your cleanroom.

If you intend to manufacture sterile injectable drugs, you must meet full CGMP requirements for sterile injectable drugs. Failure to adhere to CGMP increases the risk for contaminated drug product, which poses an unacceptable risk to patients. You must establish and follow procedures designed to prevent contamination of drug product intended to be sterile and such procedures shall include validation of any sterilization process, in accordance with 21 CFR 211.113(b).

See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71021/download.

In response to this letter, provide:

• A comprehensive assessment of your in-process monitoring and sampling operations, focusing on each (b)(4) process step that can introduce variability. Provide your remediation plan to improve: (1) in-process detection of variation; (2) (b)(4) controls; and (3) sampling plans.
• A list of chemical specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.
  o An action plan and timelines for conducting full chemical testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
  o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).

You failed to perform adequate identity testing of each component lot used in the manufacture of your drug products and you failed to verify the reliability of your suppliers’ certificates of analysis (COAs).

Water

You purchase (b)(4) water and (b)(4) water for use as a component in your drug products, including drug products you manufacture under conditions attempting to render a drug sterile, without adequately demonstrating that your water was suitable for its intended use. Your firm failed to test the (b)(4) water or (b)(4) water to determine whether they are of adequate identity, purity, strength, and other appropriate quality attributes. Additionally, you accept the water without an accompanying COA. Without adequate testing, you have no assurance that your purchased water meets minimum microbiological and chemical standards suitable for the manufacture of your drug products. Pharmaceutical water must be suitable for its intended use (e.g., minimally (b)(4) for pharmaceutical use and (b)(4) for parenteral use products) and routinely monitored using adequate methods to ensure ongoing conformance with appropriate chemical and microbiological attributes.

If your drug products are parenterally administered, water of appropriate quality must be used. Water is a primary contributor for bacterial endotoxin, and parenteral products are intended to be nonpyrogenic.

Glycerin

You use glycerin as a component in the manufacturing of your drug products such as Bryophyllum Avena Homeopathic Liquid. You failed to adequately test each shipment of each lot of glycerin for identity, a component at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination. Identity testing for glycerin and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for levels of DEG or EG. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products.

Your response states that you will update your procedures, develop a plan to test your purchased water to meet water for pharmaceutical purposes by December 31, 2025, and that you engaged a third-party laboratory for identity testing of glycerin for DEG and EG testing for current inventory and going forward.

Your response is inadequate because your corrective action for your water is not timely, and your interim plans are unclear (e.g., accept/reject, test inventory, pause production). In addition, it does not address potential impact to drug products manufactured using water of unknown quality, including drugs that may be injected. You also do not discuss your plans regarding obtaining potential failing results of glycerin obtained from current inventory for released product. Further, you did not commit to reviewing all your components to determine whether adequate identity testing is conducted and conformity with all appropriate written specifications.

In response to this letter, provide:

• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
• A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.
• A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
• A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
• A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
• A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPAs) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
• A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.
• The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.

3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Your drugs include those intended for application to broken skin and scrapes. You failed to establish laboratory controls that include scientifically sound methods to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.

• You failed to adequately validate your alternative microbiological test methods. For example, you use the (b)(4) microbiological analyzer for (b)(4) microbiological testing of your non-sterile drug products. You stated this system was validated by the manufacturer, but you did not demonstrate the system adequately quantifies and identifies objectionable microbes, and you failed to demonstrate it was scientifically sound.
• You also failed to establish scientifically sound and adequate specifications for microbial limits for your non-sterile drug products. For example, your established microbiological limits for your non-sterile dosage forms are set (b)(4) times greater than limits for similar dosage forms with the same route of administration. Furthermore, you failed to conduct adequate testing of your aqueous based non-sterile drug products for objectionable organisms such as Burkholderia cepacia.

Additionally, you failed to conduct Antimicrobial Effectiveness Testing (AET) on all of your non-sterile drug products.

The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product to be tested must be established and validated.

Your response states the (b)(4) microbiological analyzer was validated by the manufacturer, that you will test products with “higher water activity” for Burkholderia cepacia, and will perform AET if needed. Your response is inadequate because it lacks adequate scientific justification, and your interim plans remain unclear. For example, the (b)(4) Microbiology System validation report is incomplete and was not reviewed and approved by your firm. You only evaluated (b)(4) of your approximate (b)(4) products, which contain differing components and preservatives. In addition, your plans do not include testing of all aqueous dugs for Burkholderia cepacia or testing of all drugs for preservative effectiveness. Your response also did not consider a retrospective evaluation of impact to product on the market.

In response to this letter, provide a comprehensive assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.

4. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU failed to ensure adequate written procedures were in place governing manufacturing and quality oversight.

• You failed to establish and follow adequate change control procedures, including labeling changes made by production personnel and not reviewed and approved by your QU (21 CFR 211.125(a)).
• You failed to establish and follow procedures for Annual Production Review (21 CFR 211.180(e)) and Adverse Events Reporting (21 CFR 211.198(a)).
• Your batch records do not include all critical steps and verifications (21 CFR 211.188(b)).

Further, you manufacture active ingredients for drug products using batch records with inadequate instructions. Critical in-process controls and critical process monitoring, including control points and methods, should be stated in writing and approved by the QU. For example, your batch record for Aquavit Liquid, lot (b)(4), lacks documented time and temperatures for (b)(4) herbs, (b)(4) and (b)(4), collecting the (b)(4) and using a (b)(4) to (b)(4) for further processing. A lack of adequate documentation for critical steps and parameters doubts whether processes are in control and consistency between batches.

Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and reproducible. Additionally, incomplete manufacturing records deprive you of the ability to reliably conduct batch record review, adequately investigate deviations and batch failures, and to ensure a continued state of validation processes.

Your QU is not fully exercising its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality and safety.

Your response indicates that you will improve your change control processes, update your procedures, and commit to corrective action to address gaps in your batch record documentation. Your response is inadequate because you did not conduct a retrospective evaluation of access controls for all computerized systems and did not commit to investigate whether other labels were altered without QU approvals. Additionally, you did not commit to systemic evaluation of similar gaps for missing procedures.

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

In response to this letter, provide:

• A comprehensive assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are justified, reviewed, and approved by your QU. Your change management program should also include provisions for determining change effectiveness.
• A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
  o A determination of whether procedures used by your firm are robust and appropriate.
  o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
  o A complete and final review of each batch and its related information before the QU disposition decision.
  o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

Unapproved New Drugs

Based on our review of the product labeling, your Homeopathic Ampule Drug products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of your products as drugs include, but may not be limited to, the following:

“Aquilinum Taraxacum Homeopathic Ampules”
• “Use: Temporary relief of digestive upset.”

“Aurum 6X Homeopathic Ampules,” “Belladonna ex herba 6X Homeopathic Ampules,” and “Viscum Mali e pl. tota 4X Homeopathic Ampules”
• “Use: Temporary relief of headache.”

“Gelsemium Bryonia Homeopathic Ampules”
• “Use: Temporary relief of flu symptoms.”

“Nux vomica Chamomilla Homeopathic Ampules”
• “Use: Temporary relief of upset stomach.”

“Symphytum Stannum Homeopathic Ampules”
• “Use: Promotes healing of broken bones.”

Your Homeopathic Ampule Drug products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We recognize that your Homeopathic Ampule Drug products are labeled as being homeopathic drugs with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

In addition to the above-described violations, your Homeopathic Ampule Drug products present significant public health concerns because, although they are labeled for oral use, these products are packaged in glass ampules, a type of container closure system which is typically intended for packaging of sterile injectable drug products. Accordingly, these products could be mistaken for or inappropriately used as injectable drugs. We note that drug products similar to your viscum products are known to be administered parenterally in other markets (see https://www.mistletoe-therapy.org/scientific-information and https://www.cancer.gov/about-cancer/treatment/cam/hp/mistletoe-pdq), and online your viscum products are being recommended by a purported physician for injection despite being labeled for oral use.³ We have also noted that another variation of your drug product (i.e., “Viscum Abietis Series 1 Homeopathic Ampules”) is shown being injected on social media by a purported medical clinician.⁴ As mentioned above, FDA has documented that your manufacturing processes are not adequate for aseptic manufacturing of a sterile injectable drug, and there is a serious risk of harm if your Homeopathic Ampule Drug products are injected, including the risk of glass particles being injected intravenously.

Additionally, we are concerned that your labeling of liquid drugs in glass ampules for “oral use” will result in oral ingestion of the product from ampules broken open by the user with possible glass contamination, which could result in direct injury by ingesting glass fragments, e.g., lacerations to the mouth and gastrointestinal tract, and associated bleeding.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to adequately address this matter may lead to regulatory or legal action without further notice including, without limitation, seizure and injunction. Other Federal agencies may take your compliance history into account when considering the award of contracts.

Failure to address violations may be cause for FDA to withhold issuance of Export Certificates. Any violations of CGMP requirements may also be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. We may re-inspect to verify that you have completed corrective actions to address any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3003813327 and ATTN: Michael Klapal.

Sincerely,
/S/

Jill P. Furman, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research

_____________________

1 Such testing is required under 21 CFR 211.110 and 21 CFR 211.165(a). Homeopathic drugs are subject to these same requirements like other drug products; there is no exemption for homeopathic drug products from compliance with these regulations (i.e., 21 CFR 211.110(a) or 211.165(a)). Further, advances in analytical testing technology have improved the ability to detect and measure (b)(4) active ingredients, making testing feasible in the case of homeopathic drug products using contemporary, commonly available assay methods.

2 See website describing your mistletoe (or viscum) products as “injectables” that come labeled for oral use https://holistic-einstein.com/wp-content/uploads/2020/10/InstructionsForInjections-1.pdf

3 See website describing your mistletoe (or viscum) products as “injectables” that come labeled for oral use https://holistic-einstein.com/wp-content/uploads/2020/10/InstructionsForInjections-1.pdf

4 Video of a purported medical clinician injecting Uriel drug product - https://www.youtube.com/watch?v=1r_u0iID7ck