FDA 483 - Micro Labs Limited - January 30, 2025

An FDA inspection conducted at a pharmaceutical firm from January 30 to February 7, 2025, identified significant deficiencies in adherence to Good Manufacturing Practices (GMPs). The observations, documented in an FDA Form 483, reveal critical issues across quality systems, laboratory controls, and facility maintenance, impacting data integrity and product quality. A primary concern was the Quality Unit"s lack of oversight on GMP document control. Inspectors found torn original records, raw data, and metadata, including leak tester and pH meter printouts, disposed in scrap, directly violating the firm"s own good documentation practices and ALCOA/ALCOA+ principles. Specific examples highlighted inadequate control over leak testing equipment, allowing manual data manipulation and lacking secure access, alongside conflicting employee statements and missing documentation. Furthermore, laboratory controls were found to be deficient. The firm"s test procedure for Relative Content by GC-FID was inadequate, showing chromatographic patterns indicative of potential data manipulation. There was also a failure to use qualified reference standards, instead utilizing "For R&D use only" materials, and analysts were untrained for complex analytical testing. Deviations from test procedures, such as using "inhibit integration" to disregard unknown chromatographic peaks without proper investigation, were also noted. Finally, facility and equipment maintenance exhibited shortcomings, with unidentified debris found on critical production equipment like conveyor belts and ports, despite cleaning records. These observations indicate a systemic breakdown in quality assurance, requiring the firm to implement comprehensive corrective and preventive actions to ensure data reliability and drug product safety and efficacy.