FDA 483 - GMP Laboratories of America Inc - December 16, 2024

An FDA inspection of GMP Laboratories of America Inc. in Anaheim, CA, revealed critical deficiencies in laboratory data management, production controls, and documentation practices. The firm failed to maintain complete and reviewed laboratory records, establish critical process parameters for manufacturing, and document operations contemporaneously. These issues, along with inadequate equipment cleaning procedures, raise significant concerns about data integrity, product quality, and potential cross-contamination for their homeopathic drug products.