FDA WARNING_LETTER - Bi-Coastal Pharma International - January 14, 2022

The FDA inspected Bi-Coastal Pharma International's drug manufacturing facility in Shrewsbury, New Jersey, from December 15, 2021, to January 14, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations. Consequently, the firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act. Key violations include the failure to establish and follow adequate written procedures for handling drug product complaints, as evidenced by an uninvestigated adverse reaction complaint for Chlordiazepoxide HCl and Clidinium Br (21 CFR 211.198(a)). The firm also failed to establish an adequate quality unit, with responsibilities and procedures not in writing or fully followed, particularly regarding oversight of Contract Manufacturing Organizations (CMOs) and internal batch record review and release processes (21 CFR 211.22(a) and (d)). Furthermore, the firm failed to ensure personnel supervising quality-related functions possessed the necessary education, training, or experience, exemplified by the QA manager's lack of relevant background and awareness of CGMP requirements (21 CFR 211.25(b)). The FDA recommends engaging a CGMP consultant and requires a written response within 15 working days detailing corrective actions, including comprehensive assessments and remediation plans for complaint systems, quality unit functions, CMO oversight, and training programs. Failure to address these deficiencies promptly may lead to regulatory actions such as seizure, injunction, and impact on product approvals or export certificates.