FDA 483 - Bactolac Pharmaceutical, Inc. - September 24, 2025

Bactolac Pharmaceutical, Inc., a dietary supplement manufacturer in Hauppauge, NY, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to establish adequate product and component specifications, did not follow its own laboratory procedures, and lacked proper identity testing and scientific rationale for ensuring finished product quality. Several observations were repeats from a previous inspection, indicating persistent issues.