FDA WARNING_LETTER - CGA Limited - May 31, 2019

The FDA issued a Warning Letter to CGA Limited following a May 27-31, 2019 inspection of their drug manufacturing facility in Laventille, Trinidad & Tobago. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Component Testing:** Failure to perform identity and impurity testing for incoming active pharmaceutical ingredients (API) as per USP monograph, relying instead on unvalidated supplier analysis reports. 2. **Incomplete Finished Product Testing and Stability Data:** Release of topical OTC drug products to the U.S. market without critical tests like active ingredient assay and identity testing, and lacking stability data to support assigned shelf-life. 3. **Equipment Maintenance and Cleaning Validation:** Apparent rust and peeling paint on product contact surfaces of non-dedicated equipment, and unvalidated cleaning methods. 4. **Unfit Water System:** Manufacturing drug products using an unvalidated water system not adequately monitored for microorganisms, and routinely drained, leading to insanitary conditions.

The FDA deemed the company's June 18, 2019, response to the Form FDA 483 inadequate due to insufficient detail on corrective actions, validation plans, and remediation of the water system.

Additionally, "CARIB® Germicidal Soap" is cited as an unapproved new drug. It is marketed as a consumer antiseptic but contains ingredients