Ohio-based drug repackager Safecor Health has been hit with a warning letter from the FDA that cites four "significant violations," including problems that could lead to drug mix-ups.
The warning letter, posted on the agency’s website, outlines four observations in the wake of a March inspection of the company’s facility in Woburn, Massachusetts.
The violations included the company’s inadequate inspection process of the packaging and labeling facilities that could lead to product mix-ups. For example, an FDA inspector found different capsules and tablets around a blister packaging machine during the packaging of chewable aspirin tablets, although records indicated that a line clearance had been performed.
“Your firm has a history of complaints for product mix-ups and has conducted internal recalls upon customer complaints,” the FDA said in the letter.
The inspection also found the company failed to establish and follow adequate written procedures for cleaning and maintaining equipment and that it failed to test samples of each drug component “for conformity with all appropriate written specifications for purity, strength, and quality.”
Additionally, inspectors cited Safecor’s quality control unit for not adhering to drug manufacturing standards.
“Our investigators observed partially completed and torn-up manufacturing records for a lot of children’s acetaminophen and stacks of loose printed forms on a desk next to the repackaging area,” the agency said.
The FDA recommended the company hire a manufacturing consultant. If the problems are not rectified, the agency said it could withhold Safecor’s export certificates and drug approvals.
Unlike drugmakers that make their products in-house, repackagers exist to resell premade drugs with new labels.