Xiamen Wally Bath Manufacture Co., Ltd.

Your facility is registered with the U.S. Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our June 15, 2022, July 5, 2022, and July 10, 2022 requests for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Xiamen Wally Bath Manufacture Co., Ltd, FEI 3009675687, at 4F, No.217, Tianfeng Road, Northern Industry, Xiamen.

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

Following review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:

Based on the records and information you provided, you have not demonstrated that you are testing incoming raw materials, used to manufacture your drug products, to determine their identity. Specifically, when we requested whether you perform raw material identity testing, you stated that you identify the raw material by checking the certificate of analysis (COA) from the supplier. In addition, you did not test for methanol on all incoming lots of ethanol or provide your firm’s specification (or limit) for allowable methanol content in ethanol used to manufacture your drug products, such as ROADPRO Hand Sanitizer, for distribution in the United States. You stated you rely on the supplier’s COA.

Component testing is fundamental to quality. Without adequate testing, you do not have scientific evidence that your raw materials conform to appropriate specifications before use in the manufacture of your drug products.

You manufacture drugs that contain ethanol. 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 at: https://www.fda.gov/media/173005/download.

In response to this letter, provide the following for all drug products imported to the United States prior to and after our 704(a)(4) request:

The chemical and microbiological quality control specifications you use to test and release each incoming lot of component 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.

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 (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.

2. Your firm 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)).

Based on the records and information you provided, you did not demonstrate that you adequately test your OTC finished drug products prior to release for distribution to the United States. Specifically, in response to our request to provide release specifications of U.S. products and the test methods used to evaluate them, you provided finished product specifications that included only test results from “(b)(4)” with microbial specifications.

Full release testing, including identity, strength, and impurities, must be performed prior to drug product release and distribution. Without adequate testing, there is no scientific evidence to assure that your drug products conform to appropriate specifications before release.

In response to this letter, provide the following for all drug products imported to the United States prior to and after our 704(a)(4) request:

A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.

o An action plan and timelines for conducting full chemical and microbiological 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.

3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

You did not provide adequate stability data to demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period. Specifically, you reported that the expiry period assigned and applied to your hand sanitizer products is (b)(4). However, you provided only 13-week stability data to support the (b)(4) expiry period.

In addition, your stability data does not include testing for identity and strength. Therefore, the data does not demonstrate that the drug’s active ingredient is stable throughout its shelf life. Also, the information provided does not include microbiological stability data.

Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.

In response to this letter, provide the following for all drug products imported to the United States prior to and after our 704(a)(4) request:

A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:

o Stability indicating methods o Stability studies for each drug product in its marketed container-closure system before distribution is permitted o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid o Detailed definition of the specific attributes to be tested at each station (timepoint)

All procedures that describe these and other elements of your remediated stability program

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 if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive 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.

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.

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.

FDA placed your firm on Import Alert 66-40 on November 8, 2023.

Correct any violations promptly. 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 inspect to verify that you have completed corrective actions to any violations.

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Xiamen Wally Bath Manufacture Co., Ltd., 4F, No.217, Tianfeng Road, Northern Industry, Dist. Jimei, Xiamen, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated or misbranded may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) and are misbranded under section 502 of the FD&C Act, respectively.

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 3009675687 and ATTN: Chhaya Shetty.