Bahamian Drugmaker Draws Warning Letter for Validations, SOPs
A generic drug manufacturer in the Bahamas drew a warning letter from the FDA and was placed on an import alert for cGMP violations at its Freeport City facility, including inadequate validations and testing.
Coral Pharmaceuticals, which also serves as a contract manufacturer, made a homeopathic drug product derived from a toxic ingredient, but lacked adequate process validation data to show the drug met safety and quality standards.
The agency also flagged the lack of identity testing for a drug component containing a toxic ingredient, which the firm released for use in manufacturing.
“Your data does not support that the drug product…is the concentration specified on the drug product label,” the agency said.