FDA EIR - GMP Laboratories of America, Inc. - January 14, 2020

A routine FDA Current Good Manufacturing Practice (cGMP) inspection of GMP Laboratories of America, Inc., located in Anaheim, CA, was conducted from October 28 to November 6, 2019. The inspection, focusing on the manufacturer of homeopathic drug products, resulted in five observations detailed on an FDA Form 483. Key issues identified included deficiencies in the quality control unit, specifically the absence of change control or risk analysis for facility renovations that occurred while manufacturing was active. Production and process controls were found lacking, with no established critical parameters like compression speed recorded in batch records, and a complete absence of process validation for homeopathic drug products. Furthermore, the suitability of microbiology testing methods for these products had not been validated. Equipment surfaces directly contacting drug products were compromised, exemplified by a cracked silicone gasket on a packaging line hopper, making cleaning difficult and risking product alteration. Finally, the facility failed to maintain separate or defined areas to prevent contamination, as evidenced by unapproved, quarantined drug product batches being stored in the "released" section of the warehouse. These observations indicated deviations from cGMP regulations. Management acknowledged the findings and committed to providing a written response to the FDA within 15 business days, outlining their corrective actions.