FDA 483 - CGA Limited - May 31, 2019

An FDA inspection of CGA Limited, an OTC drug manufacturer in Laventille Trinidad & Tobago, revealed significant deficiencies across its quality control, production, and laboratory systems. Observations included a lack of written procedures, inadequate investigations into failing batches, unmaintained and unvalidated equipment, and insufficient testing and documentation for product release and stability. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices.