Bioasia Worldwide Sdn Bhd – FDA Warning Letter, Oct 17, 2024

The FDA inspected BioAsia Worldwide Sdn Bhd's drug manufacturing facility in Malaysia from October 14-17, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The company's November 4, 2024, response to the FDA 483 was deemed inadequate due to insufficient documentation and evidence of corrective actions.

Key violations include: 1. **Failure to conduct identity testing for drug product components and validate supplier test analyses (21 CFR 211.84 (d)(1) and (d)(2)).** The firm relied on supplier COAs without verification and failed to demonstrate component compliance with USP specifications. 2. **Failure to perform appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.165(a)).** The company relied on physical/organoleptic testing and lacked adequate strength and microbiological testing. 3. **Failure to establish an adequate written stability testing program (21 CFR 211.166(a)).** Stability studies were insufficient, lacking full shelf-life evaluations and strength testing at all time points. 4. **Failure to establish written procedures for production and process control, including process validation, equipment qualification, and cleaning validation (21 CFR 211.100(a)).