Guangxi Yulin Pharmaceutical Group Co. Ltd. — FDA Warning Letter Findings

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)). Your firm failed to adequately determine the appropriate laboratory testing necessary for your (b)(4) over the counter (OTC) drug products. For example, you did not perform testing for identity and strength of…

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)). Your firm failed to demonstrate that your test methods were appropriate to assure that your…

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your laboratory equipment lacked sufficient controls to prevent and detect deletion or manipulation of your laboratory's electronic raw data. For example, your ultraviolet-visible (UV-vis) and infrared (IR) spectroscopy equipment was found to lack…

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). Your firm does not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products meet established specifications and remain acceptable throughout their labeled shelf life. For example, you have not established an appropriate stability program (e.g., frequency and methods) to assess stability characteristics, to ensure that your drug products meet their appropriate strength and quality attributes through their (b)(4) shelf life. In your response, you propose to perform tests once a year during the stability test period. However, your response is inadequate because you do not provide scientific rationale or a formal written risk assessment to support this yearly frequency. Without appropriate stability studies, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.