Zhejiang Uniquality Nursing Products Technology Co., Ltd. dba ZheJiang YouQuan Care Products Technology Co., Ltd.

Warning Letter 320-25-14

November 12, 2024 Dear Mr. Zhou:

Your facility is registered with the United States 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 March 11, 2024 and April 15, 2024 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, Zhejiang Uniquality Nursing Products Technology Co., Ltd., FEI 3012557963, at No. 68 Luhui Road, Taihu Street, Changxing County, Huzhou, Zhejiang 313100, China.

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 of drugs as described in your responses to our 704(a)(4) requests 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)).

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:

1. 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 (21 CFR 211.84(d)(1) and 211.84(d)(2)).

You manufacture over-the-counter (OTC) drug products such as (b)(4). Based on the records and information you provided, you did not demonstrate that you adequately tested incoming raw materials used in the manufacture of your drug products. Specifically, you failed to conduct adequate identity testing on incoming raw materials. Additionally, your firm relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics at appropriate intervals.

(b)(4) & (b)(4)

You failed to demonstrate that you adequately test each shipment of each lot of (b)(4) and (b)(4) for identity, components at higher risk for (b)(4) and (b)(4) contamination. Identity testing of (b)(4) and (b)(4), along with other high-risk drug components1, include a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of (b)(4) or (b)(4). Because you did not perform identity testing on each shipment of each (b)(4) lot and (b)(4) lot using the USP identification tests that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.

(b)(4)

Your firm uses (b)(4) as a component in your drug products. Your firm has not demonstrated that the (b)(4) is suitable for use and meets the USP (b)(4) monograph.

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

2. 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)).

Based on the records and information you provided, you did not demonstrate that you established an appropriate specification for the strength of your active ingredient (b)(4) in your drug product. For example, the records you provided included a stability specification for (b)(4) content of (b)(4)%, which you indicated is for “the surface of the (b)(4), (b)(4)% is for the whole product.” You have not demonstrated that your specification assures that your finished drug product meets its specification for strength of the active ingredient (b)(4) of not less than (b)(4)% for the duration of its shelf life.

Without appropriate testing specifications, you do not have scientific evidence to support whether your drug products meet their established specification for strength of the active ingredient (b)(4) through their labeled expiry.

3. 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)).

Based on the records and information you provided, you did not demonstrate that your quality unit (QU) effectively exercised its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU did not adequately exercise its authority in the approval or rejection of components in your Materials System.

Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations. 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.

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.

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 12, 2024.

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 Zhejiang Uniquality Nursing Products Technology Co., Ltd., at No. 68 Luhui Road, Taihu Street, Changxing County, Huzhou, Zhejiang 313100, China, 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 may be detained or refused admission.

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 3012557963 and ATTN: Joel Hustedt.