FDA EIR - Bell Pharmaceuticals, Inc - April 06, 2018

An FDA surveillance inspection of Bell Pharmaceuticals, Inc., a manufacturer of over-the-counter and homeopathic drugs, was conducted from April 2 to April 6, 2018. The inspection assessed compliance with Good Manufacturing Practices (GMP) regulations. Six main observations were detailed in an FDA-483 form issued to management. Key issues included a stability program that lacked specific test methods, notably failing to test for impurities or demonstrate stability-indicating assays. Drug products, raw materials, and reserve samples were not stored under monitored temperature and humidity conditions, raising concerns about product integrity over prolonged storage. Computer systems and related records lacked adequate controls, allowing for potential unauthorized changes to data and deletion of raw files, and loose-leaf logs were not properly controlled. Furthermore, essential records, such as the QC Director's training, adverse event evaluations for complaints, and corrective action documentation, were not readily available. The facility also exhibited deficiencies in segregating areas for quarantined and rejected materials, posing risks of contamination or mix-ups. Lastly, a critical HPLC system lacked routine calibration, impacting analytical reliability. Management committed to providing a written response to the observations within 15 days, outlining their corrective actions.