Perrigo Gets FDA Warning Letter Over Tainted Ibuprofen

Perrigo, manufacturer of nonprescription, store brand medications, received a warning letter from the U.S. Food and Drug Administration (FDA). The drug maker was told, quoted Fierce Pharma, “Be advised that FDA expects that your corporate management will undertake a comprehensive evaluation of manufacturing operations to ensure compliance with CGMP.”

The FDA conducted an inspection from midNovember last year, through midJanuary, said Fierce Pharma. According to the warning, Perrigo did not reject one lot of <"">ibuprofen tablets contaminated with metal shavings. While Perrigo did separate the contaminated portion, it shipped a sub-portion of the contaminated lot, said Fierce Pharma. The entire lot was ultimately recalled.

Also, Perrigo did not appropriately explain how a foreign tablet ended up in its filling equipment, said Fierce Pharma, noting that one lot of brown, oval ibuprofen caplets contained a brown, round tablet. And, the firm did not inspect a lot of orange, round ibuprofen tablets that were packaged in between the other pills, said Fierce Pharma. “There is no assurance that this lot was not also contaminated,” said the FDA’s letter.

According to the FDA letter, its inspection of Perrigo’s pharmaceutical manufacturing facility “identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals,” which caused the “drug product(s) to be adulterated.” After its review, the FDA said that it found Perrigo “lacks sufficient corrective actions” and noted a variety of violations, which include, in part that Perrigo/Perrigo’s:

• “failed to reject a lot of lbuprofen Tablets … contaminated with metal shavings due to an equipment failure.”

• “did not thoroughly investigate possible foreign tablet contamination in your filling equipment.”

• Quality Control Unit (QCD) “failed to follow SOP” (standard operating procedure) concerning the “editing and verifying label content for Cherry Flavored Milk of Magnesia. Failure to follow your written procedure resulted in release of mislabeled product,” which was recalled.

• QCD failed to follow SOP regarding “verifying the accuracy of label ingredient disclosure quantities of magnesium and calcium in Regular and Mint Flavored Milk of Magnesia and identifying incorrect values as changes from expected label specifications. Failure to follow your written procedure resulted in release of mislabeled product, which” was recalled.

• Failed “to follow” SOPs “during the last three FDA inspections, as well as in other inspections since 1998. Although your February 1, 2010 response acknowledges the procedural errors and recalls in both examples above, your response does not provide the corrective actions your firm plans to take to prevent reoccurrences in the future.

• ”failed to adequately inspect the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations,” which included a laundry list of failures cited as a result of the agency’s investigation.

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