Loading…
Bell International Laboratories, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of over-the-counter drug products, rendering them adulterated. The company's quality unit failed to establish adequate control procedures and did not properly investigate non-conformances, customer complaints, or out-of-specification test results, while also maintaining incomplete batch records and testing documentation. The FDA inspection in September 2023 found that the quality unit lacked written procedures and failed to follow the procedures that did exist, and although the company acknowledged these deficiencies in its response and committed to more thorough investigations, the violations demonstrated systemic failures in quality oversight and documentation.