Purolea Cosmetics Lab

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Purolea Cosmetics Lab, FEI 3011669383, at 12782 Currie Ct., Livonia, from October 28 to 30, 2025.

Your drug products are adulterated under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(A), in that they have been prepared, packed, or held under insanitary conditions.

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 FD&C Act, 21 U.S.C. 351(a)(2)(B).

In addition, the FDA reviewed the product labels for drug products manufactured at your facility, including "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief." Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). These drug products are especially concerning from a public health perspective as they are intended to treat serious and/or life-threatening conditions such as shingles and genital herpes.

We acknowledge receipt of your response to our Form FDA 483. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.

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

Your drug products are adulterated under section 501(a)(2)(A) of the FD&C Act because they were prepared, packed, or held under insanitary conditions. During the inspection, our investigator observed the presence of insects, filth, leaves, and clutter in several areas within your facility.

Furthermore, your facility lacked adequate separation to prevent contamination from other internal or external contaminants. For example, the facility docking bay door, when opened, would directly expose manufacturing to the outside environment.

You manufacture multiple (b)(4) homeopathic drug products. Some of these products can be used to (b)(4). Additionally, some products may be used (b)(4).

Your firm released your finished homeopathic drug products without testing for microbiological attributes (e.g., total count, objectionable microorganisms). Without testing each batch prior to release, you did not have scientific evidence that all drug product batches were free of objectionable microbial contamination.

Your firm failed to conduct testing for (b)(4) for non-sterile (b)(4) drug products prior to release and at appropriate intervals for stability. See FDA’s guidance document, Microbiological Quality Considerations in Non-sterile Drug Manufacturing, for help minimizing the risks of harmful microbiological contamination of (b)(4) drugs at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microbiological-quality-considerations-non-sterile-drug-manufacturing.

Drug products that do not meet quality standards can pose a safety risk to the public.

2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(1) and 211.84(d)(2) and 211.84(d)(6)).

You failed to perform adequate testing for purity, strength, quality, and identity for the components used in the manufacture of your (b)(4) drug products. In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

(b)(4)You failed to test your purchased bulk (b)(4) to assure it was of acceptable quality for use in drug production. You also failed to establish the reliability of your component supplier at appropriate intervals. Your firm has not demonstrated that the (b)(4) was suitable for its intended use, tested for microbiological quality, and minimally met the United States Pharmacopeia (USP) (b)(4) monograph.

(b)(4) must be suitable for its intended use. Each lot must be tested to ensure conformance with appropriate chemical and microbiological attributes. Routine monitoring of microbial counts as well as characterization and identification of contamination is integral to ensuring (b)(4) is of acceptable quality for use in manufacturing operations.

Of note, you did not test the (b)(4) for (b)(4), a contamination risk in (b)(4) drug products, which has been linked to (b)(4). For further information regarding the significance of (b)(4) contamination of (b)(4) drug products, see FDA’s advisory notice at (b)(4).

Ingredients at Risk for (b)(4) ContaminationYou failed to adequately test your incoming components at high risk of (b)(4) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of (b)(4) to determine its appropriate identity. The identity testing of (b)(4) includes a limit test, according to the USP, to ensure that the component meets the relevant safety limits for the levels of (b)(4).

The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, (b)(4).

Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products.

3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure:

Procedures were established or followed (21 CFR 211.22(d))

Batch records were reviewed before drug product release (21 CFR 211.22(a))

Adequate production and process controls were established (21 CFR 211.100(a))

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.

During the FDA inspection of your drug manufacturing facility, you stated to FDA investigators that you utilized artificial intelligence (AI) agents (b)(4) to help your firm comply with FDA regulations. Specifically, you used AI to create drug product specifications, procedures, and master production or control records to be in compliance with FDA requirements.

If you use AI as an aid in document creation, you must review the AI generated documents to ensure they were accurate and actually compliant with CGMP. Your failure to do so is a violation of 21 CFR 211.22(c). Overreliance on artificial intelligence for your drug manufacturing operations was also documented during the inspection. For example, the FDA investigators found that you had not conducted process validation prior to distribution of your drug products, as required under 21 CFR 211.100, and informed you as such. You replied that you were not aware of the legal requirement, as the AI agent you used (b)(4), never told you it was required.

We recognize that you have ceased drug production. If you plan to resume drug production, and use AI to help with CGMP activities, such as development of procedures and specifications, any output or recommendations from an AI agent must be reviewed and cleared by an authorized human representative of your firm’s QU in accordance with section 501(a)(2)(B) of the FD&C Act. See also 21 CFR 211.22; 21 CFR 211.100.

We acknowledge your commitment to cease production and distribution of drugs at this facility.

Even though you indicated your firm is no longer manufacturing products at your facility, there are still products within expiry in U.S. distribution. Data is required to support whether your components and your drug products meet established specifications (such as identity, strength, quality, and purity) and that these drug products will remain within acceptable limits and retain their quality attributes through their labeled shelf-life until expiry.

In response to this letter:

Specify by National Drug Code (NDC) number which drugs have been discontinued and the last day of manufacture.

Clarify your intentions for the drug products that remain on the market within expiry.o Explain how distributed drug products will be verified to ensure they meet specifications.o Confirm that if you receive any client or customer complaints and/or any results from ongoing testing or evaluation that reveal substandard quality for the drug components, active pharmaceutical ingredient (API), or distributed drug products, that rapid corrective action should be taken for products that were released for commercial distribution and that are still within expiry, such as notifying customers and product recalls.

Provide commitment that if you intend to resume manufacturing drugs at this facility or any other facility in the future, that you will notify this office prior to resuming your drug manufacturing operations.

If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, 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 all corrective action and preventive action, before you pursue resolution of your firm’s compliance status with FDA.

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of your drugs regardless of agreements in place with a contract facility. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

If your firm does not intend to engage in any further drug manufacturing activities, then you, as the owner and operator of the drug manufacturing establishment, are required to update all outdated information to avoid miscommunication or errors. Consequently, your firm will need to modify the drug product marketing status and delist each product with the last lot expiry date as the “marketing end date” on the specific product listing per 21 CFR 207.57(b)(1)(ii).

Additionally, after delisting your drug products, you will need to deregister your overall drug establishment with FDA if you cease manufacturing and distributing drugs in U.S. per 21 CFR 207.29(a)(1). If you have any further registration or listing questions, please contact the EDRLS general mailbox: eDRLS@fda.hhs.gov.

Based on a review of the product labels collected during the inspection, "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are drugs under 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 of claims from the product labels that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but are not limited to, the following:

"SHINGLES"

"GENITAL HERPES RELIEF"

"Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" 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 (GRASE) 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 sections 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 "Dermveda Extra Strength Shingles Relief" and "Dermveda Extra Strength Ultra Genital Herpes Relief" are labeled as homeopathic drugs. 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, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

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 promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. 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 3011669383 and ATTN: Frank Wackes.