FDA WARNING_LETTER - International Laboratories Corp - September 20, 2024

The FDA inspected International Laboratories Corp in Thailand from September 16-20, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm lacked complete and reliable original data for chromatographic analyses of OTC drug products and components. Investigators found fabricated laboratory records and investigations, confirmed by the Laboratory Manager and a senior Quality Assurance Manager. Original data for raw materials and finished products was not maintained. The firm's response acknowledging data integrity (DI) deficiencies was deemed inadequate for not evaluating the full scope of issues. 2. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Laboratory equipment used for analytical data lacked restricted access and sufficient controls. Investigators documented deleted electronic raw data files, and analysts had administrative rights to alter/delete data, files, and folders, including test dates/times. Complete electronic raw data was not retained for all instrumentation. The firm's response was inadequate for not including a comprehensive review of equipment or the impact of discarded/lost data. 3. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The Quality Unit failed to provide adequate oversight, unable to provide records supporting CGMP requirements for drug manufacture. The firm's response