The FDA cited a skincare product manufacturer in a warning letter for significant violations of cGMP for finished drugs and APIs, along with several misbranding issues.
The agency issued a warning letter last month to Pharmco Laboratories based on an investigation from Nov. 9 to 30 in 2015. It posted the warning letter on Tuesday. Even though the company emphasizes on its website that “we manufacture all products under FDA and strict cGMP guidelines,” the FDA found otherwise.
In the warning letter, the agency listed four violations with finished drugs, four API deviations, and several misbranded OTC drugs.
According to the FDA, the Florida-based company didn’t have written procedures for monitoring its manufacturing processes, didn’t formulate sound test methods or an adequate written testing program, and failed to establish appropriate laboratory controls.
With the exception of only one product, the company has “no scientific data to demonstrate the antimicrobial effectiveness of the preservatives in your topical OTC drug products,” noted the agency in the warning letter.
For APIs, the agency found that the company didn’t have any validated process to prove that it was producing drugs with consistent quality. What’s more, the agency admonished the facility for using a dryer for APIs that was also used in the manufacture of dietary supplements containing soybeans—a major food allergen—without having adequate procedures for the cleaning of equipment.
The FDA said it had previously uncovered those two violations, along with failure to establish an impurity profile, in two previous inspections in 2006 and 2008.
“These repeated lapses demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs,” said the FDA warning letter.
In addition, the FDA faulted the company for not having enough information conspicuously labeled for several acne products, and for using ambiguous and unpermitted language on the labels of several sunscreen products, among other violations of regulations.