Guangzhou Tinci Materials Technology Co., Ltd. – FDA Warning Letter, Aug 2, 2019

On January 23, 2020, the FDA issued a Warning Letter to Guangzhou Tinci Materials Technology Co., Ltd. following an inspection from July 29 to August 2, 2019. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals, rendering their drug product adulterated. The firm manufactures an API, (b)(4), which is then mixed into an in-process material, (b)(4), for a finished drug product.

Key violations include: 1. **Inadequate Equipment Design and Monitoring (21 CFR 211.63):** The firm failed to adequately monitor their (b)(4) system, not testing for TAMC and TYMC at the time of drug product batch (b)(4) manufacture, leading to an out-of-limit result (255 cfu/mL for TAMC) when tested later. The (b)(4) system also exhibited design flaws (dead-legs) and poor maintenance (corrosion on pipes, fittings, valves, and tanks). 2. **Failure to Conduct Appropriate Laboratory Testing (21 CFR 211.165(b)):** Drug product batch (b)(4) was released without adequate microbial limit testing. The FDA requires a list of chemical and microbial specifications, an action plan for testing retain samples of all distributed batches within expiry, and a comprehensive assessment of laboratory practices. 3