FDA WARNING_LETTER - BBC Group Limited - March 26, 2021

On August 4, 2021, the FDA issued a Warning Letter to BBC Group Limited following an inspection from March 22-26, 2021, at their drug manufacturing facility in Zhangzhou, China. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Data Integrity Lapses (21 CFR 211.68(b)):** The firm failed to control computer systems adequately. Analytical data from 2018-2020 for gas chromatograph (GC) testing was lost and unrecoverable. GC systems lacked restricted access, with all laboratory employees logging in as "System Administrator" without passwords, and audit trails were not enabled. Dynamic data from other lab equipment (viscometer, UV-Vis spectrophotometer) and electronic spreadsheets for stability programs were not saved or controlled, allowing for potential manipulation. The firm's response was inadequate, lacking supporting documentation for corrective actions and a retrospective risk assessment. 2. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** Analytical test methods, including those for ethanol and an impurity, were not adequately validated. System suitability requirements were absent, and reference standards were not identified. The firm's response lacked details on reference