FDA 483 - BBC Group Limited - March 22, 2021

BBC Group Limited, a drug manufacturer in Zhangzhou, China, was cited for significant deficiencies in data integrity, quality control, and manufacturing practices during an FDA inspection. Observations included missing electronic data backups, inadequate computerized system controls, unvalidated analytical methods, and failures in stability testing, batch recordkeeping, equipment logs, equipment maintenance, and annual product reviews. These issues indicate a systemic lack of control over critical aspects of drug product manufacturing and quality assurance.