FDA WARNING_LETTER - Fulijaya Manufacturing Sdn. Bhd - July 18, 2025

The FDA issued a Warning Letter to Fulijaya Manufacturing SDN. BHD. following an inspection conducted from July 14-18, 2025. The letter cited significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), leading to the company"s drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues included the failure to ensure complete and original laboratory records, specifically lacking raw data for microbiological release and stability testing, which compromised data integrity. Additionally, the firm failed to establish adequate laboratory controls, exemplified by not performing growth promotion testing for microbiological media or testing a critical component for *Burkholderia cepacia complex*. Finally, the company lacked an adequate stability testing program, with insufficient assay testing for active ingredients and no evaluation for impurities, failing to demonstrate product quality throughout its labeled expiry.

The FDA requires comprehensive investigations into data integrity lapses, risk assessments, and the implementation of a global Corrective and Preventive Action (CAPA) plan. Further required actions include an independent assessment and remediation plan for laboratory practices, retesting of retain samples for distributed products, and a retrospective review of growth media. A comprehensive independent assessment and CAPA for the stability program are also mandated. The FDA strongly recommended engaging a qualified CGMP consultant and requires a written response within 15 working days detailing all corrective actions and a timeline for completion.