FDA 483 - Brands International Corporation - June 21, 2024

An FDA inspection conducted from June 17-21, 2024, at Brands International Corporation, an Over-the-Counter (OTC) drug manufacturer in Newmarket, Canada, revealed 19 significant observations regarding non-compliance with Current Good Manufacturing Practices (CGMP). The findings highlighted a severely deficient Quality Control (QC) unit that lacked proper authority, failed to adequately investigate product discrepancies (including a mold contamination complaint initially undisclosed), and maintained insufficient records for critical procedures such as complaints, corrective actions, and batch reviews. The company released drug products without complete final specification testing and exhibited inaccurate batch record-keeping. Personnel training and understanding of CGMP principles were inadequate, and essential processes like manufacturing and cleaning lacked validation. Furthermore, analytical and microbiological test methods were unvalidated, and raw material sampling was unrepresentative. The facility displayed poor material handling and storage conditions, including pest infestations and the use of expired raw materials. Complaint handling, annual product reviews, and the reserve sample program were all found to be insufficient. Brands International Corporation is expected to implement comprehensive corrective and preventive actions to address these systemic issues and achieve full regulatory compliance for its OTC drug products.