---

---

---

Warning Letter 320-25-115

September 25, 2025

Dear Mr. Purohit:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Naturich Cosmetique Labs, FEI 3008480436, at 2505 Merritt Drive, Garland, from April 28 to May 2, 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).

We reviewed your May 22, 2025, response to our Form FDA 483 in detail. 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.

1. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Inadequate Water System

Your firm uses water as a component to manufacture topical over-the-counter (OTC) drug products including skin protectants applied to irritated and potentially broken skin of infants. You failed to adequately validate your water production process to ensure the system was consistently producing water of appropriate quality for its intended use. Additionally, your water system was not adequately maintained nor periodically sanitized. Furthermore, you failed to demonstrate that your water system was adequately monitored to ensure it consistently produced water that met appropriate chemical and microbial quality standards.

In your response, you commit to hiring a third-party laboratory to perform conductivity and total organic carbon testing of your water system. However, your response is inadequate because you did not include timeframes for completing microbiological testing, including appropriate microbial enumeration and identification of water system sample isolates.

Additionally, you failed to consider inadequate aspects of your water system design (e.g., ambient temperature not otherwise subjected to sanitization processes) to ensure it is suitable for producing water used in the formulation of your drug products. Further, you do not address the potential impact of a poorly designed water system to drug products distributed within the United States that are within expiry.

(b)(4) water must be suitable for its intended use and routinely tested. To achieve an ongoing state of control in your (b)(4) water system, you must conduct routine monitoring of microbial levels and identify any contamination in the system.

Inadequate Process Validation

You have not validated the processes you use to manufacture your OTC drug products. You failed to ensure adequate documentation and control over critical processing steps (e.g., blend times, speeds, temperatures, durations, and specific equipment) used for your large-scale, weight-based manufacturing processes. You distributed drug products with intra-batch potency variability, which indicated inadequate controls for mixing to ensure uniformity. Examples included:

• A lot of sub-potent Acne Moisturizing lotion that was re-tested and subsequently released without adequate justification for the initial failing result.
• A lot of super-potent (b)(4) SPF 30 lotion that repeatedly failed in-process testing and finished product release testing. Additionally, this lot was released after attempts to reprocess the in-process material, including blending with additional inactive components.

In your response, you commit to developing a master validation plan and a standardized process validation protocol for each of your OTC topical drug products. Your response is inadequate because you did not describe interim controls while process validation is pending or consider a retrospective assessment of the potential impact to your products distributed within the United States that are within expiry.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs.

Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluates batches to determine whether an initial state of control has been established.

Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.

In response to this letter, provide:

• A comprehensive, independent, assessment of your water system design, control, and maintenance.
• A thorough remediation plan to install and operate a suitable water system. Include a robust ongoing control, maintenance, and monitoring program to ensure the remediated system design consistently produces water adhering to (b)(4) Water, United States Pharmacopoeia (USP) monograph, specifications and appropriate microbial limits.
• Regarding the latter, ensure that your total microbial count limit for water is appropriate in view of the intended use of the products produced by your firm.
• A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
• A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
• A timeline for performing process performance qualification for each of your marketed drug products.
• Process performance protocol(s), and written procedures for qualification of equipment and facilities.
• A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.

2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

You failed to adequately investigate multiple microbiological out-of-limit (OOL) results from your (b)(4) water system used to manufacture topical drug products. For example, from May 2024 through April 2025, you did not adequately investigate several OOL testing results from your water system, including the recovery of objectionable microorganisms from multiple points of use. These microorganisms included, but were not limited to Enterobacter cloacae (a common fecal microbiota), Burkholderia cepacia, and multiple Pseudomonas sp. Your investigation did not include an adequate corrective action and preventive action plan (CAPA) to prevent the use of components with potentially objectionable microbial contamination from being used in the manufacture of your drug product.

Furthermore, your justification to release associated finished product relied on subjecting finished products to poorly documented processes you identified as a “(b)(4) step of mixing temperature above that which gram-negative bacteria can withstand.”

In your response, you fail to include an adequate CAPA for controlling microbial recoveries from your water system, stating you continue to rely on “(b)(4) step” processes of (b)(4) batches to (b)(4) to ensure they are free of any microbial contamination. You also fail to consider how fundamental flaws in design, control, and maintenance of your water system may contribute to the OOL results of water.

Your CAPA is not sufficient to ensure the production of water, used as a component, is suitable for its intended use. Your investigations are limited in scope and lack comprehensive review for potentially affected products produced with inadequate water as well as root cause determination. You also did not provide any supporting documentation, including details of your corrective actions with your response. Well-documented, thorough, and scientifically sound investigations are necessary to identify the root cause and implement the appropriate and effective CAPA.

In response to this letter, provide:

• A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit (QU) oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
• An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final QU decisions, and is fully supported by executive management.
• A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards.
• Complete investigations into all batches with potential objectionable microbial contamination or an OOS microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.
• Appropriate microbiological batch release specifications (i.e., total counts, identification of bioburden to detect objectionable microbes) for each of your drug products.
• All chemical and microbial test methods used to analyze each of your drug products.
• A summary of results from testing retained samples of all 365 (b)(4) Baby Diaper Cream drug product batches within expiry. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients and microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an OOS result, indicate the corrective actions you will take, including notifying customers and initiating recalls.

3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm manufactures OTC topical drug products, including but not limited to hand sanitizer and skin protectants. You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., ethyl alcohol, glycerin) used in the manufacture of your OTC topical drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Products Containing Ethyl Alcohol

You failed to adequately test your incoming component ethyl alcohol (ethanol) at risk of methanol contamination for identity before using it as an active pharmaceutical ingredient (API) in manufacturing your OTC topical drug products. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-testing-alcohol-ethanol-and-isopropyl-alcohol-methanol.

Furthermore, you failed to demonstrate that the component ethanol, used to manufacture your hand sanitizer drug products, meets USP monograph specifications or is of adequate quality for its intended use.

Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol Contamination

You also failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity, prior to use in manufacturing your OTC topical drug products.

Identity testing for glycerin and certain other high-risk drug components includes a limit test in the USP to ensure the component meets the relevant safety limits for DEG or EG levels. 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/regulatory-information/search-fda-guidance-documents/testing-glycerin-propylene-glycol-maltitol-solution-hydrogenated-starch-hydrolysate-sorbitol.

In your response, you state that your vendors for glycerin and ethyl alcohol are qualified and their COAs are accurate. You also commit to implement additional tests for a few incoming glycerin and ethyl alcohol batches specifically used in your topical OTC drug products. Your response is inadequate because you do not provide sufficient details and supporting data to demonstrate that your components meet all compendial requirements.

Furthermore, your response does not address testing each shipment of each lot, including each container, of your high-risk drug components for DEG or EG contamination and ethanol for the presence of methanol contamination. Also, you do not commit to retrospective testing of retained components or finished products, and you do not address potential impact on drug products in the U.S. market within expiry.

Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products. You have a responsibility to sample, test, and examine drug components before use in production to ensure acceptable quality parameters are met.

In response to this letter, provide:

• A comprehensive, independent 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.
• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
• 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 re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of alcohol, isopropyl alcohol, glycerin, and certain additional high-risk components, we note that this includes the performance of parts A, B, and C of the USP monograph.
• A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP 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 commitment to provide methanol test results, no later than 30 calendar days from the date of this letter, for retains for all lots of components of manufactured drug products within expiry. 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 methanol.
• 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 CAPA 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.

Quality Systems

Your firm’s quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see these FDA guidance documents:

• Q8(R2) Pharmaceutical Development at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-development
• Q9 Quality Risk Management at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-management
• Q10 Pharmaceutical Quality System at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q10-pharmaceutical-quality-system

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 evaluate your operations and 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 corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.

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.

Responsibilities as a Contractor

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 drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry.

Cosmetics Manufactured for Distribution in the United States

In addition, we note that 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. 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.

Further, your facility may be subject to requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Information on MoCRA requirements may be found at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.

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 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 3008480436 and ATTN: Matthew R Dionne, Compliance Officer.

Sincerely,
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
 

CC:
Kevin M. Hilbert
Director, Regulatory Affairs
Naturich Cosmetique Labs
2505 Merritt Drive
Garland, TX 75041-6158