FDA Issues Warning Letter to Perrigo Over Metal Shavings in Ibuprofen Tablets

The Detroit Free Press on May 28th reported about the FDA Warning letter sent to Perrigo Company, a generic drug developer and the largest US maker of store-brand, over-the-counter drugs.

The article written by Lori Higgins highlights the four significant violations cited by the FDA during inspections from November 17-January 14:

· Perrigo did not reject a lot of ibuprofen tablets that were contaminated by metal shavings due to an equipment failure. The FDA said that although Perrigo segregated a portion of the affected lot, it still shipped some of the lot. That resulted in a recall of the entire lot.

· Perrigo didn’t thoroughly investigate possible foreign tablet contamination in its filling equipment when it found a brown, round ibuprofen tablet from one lot included in a lot of brown, oval ibuprofen caplets. The FDA said the company should have investigated a lot of orange, round ibuprofen tablets that were packaged between the packaging of the brown, round tablets and the brown, oval caplets to ensure there was no further contamination.

· Perrigo’s quality control unit failed to follow standard operating procedures, twice resulting in the release of mislabeled products that had to be recalled.

· Perrigo failed to adequately inspect packaging and labeling facilities before use to ensure drug products had been removed from previous operations.

Additionally Ms. Higgins quotes Joann M. Givens, District Director of the Detroit FDA office in the letter. "Your firm has had an ongoing program since 2005 to address mixups. ... However, your firm continues to receive complaints regarding this issue, and despite past assurances that previous enhancements would control this problem, deviations continue."

To read the entire Detroit Free Press article, visit:
http://www.freep.com/article/20100527/BUSINESS06/100527055.

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