FDA 483 - Coral Pharmaceuticals LTD - May 24, 2019

Coral Pharmaceuticals LTD, a homeopathic drug manufacturer in Freeport City Bahamas, was cited for significant deficiencies across its quality control, equipment, production, and laboratory control systems. The inspection revealed a pervasive lack of written procedures, inadequate training, insufficient quality oversight, and failures in equipment qualification, calibration, and product testing, indicating a fundamental breakdown in cGMP compliance.