Linghai ZhanWang Biotechnology Co., Ltd — FDA Warning Letter Findings

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)). Your firm manufactured OTC drug products, including anti-microbial wipes. Based on the records and information you provided, you did not demonstrate that you are adequately testing the identity of components used in the manufacture of your drug products. For example, you did not…

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)). The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your OTC drug manufacturing operations. Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding drug 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.

Your firm failed to establish 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)). The records and information you provided did not demonstrate that your firm has an adequate stability program for the OTC anti-microbial wipes you manufacture. For example, you conducted stability studies under “accelerated aging experiments” for your anti-microbial wipes without scientific justification. These experiments were conducted over a (b)(4) period at (b)(4) °C and 75% relative humidity. In addition, you did not perform stability studies under long-term storage conditions to support the (b)(4) expiration date on the label. 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.