FDA: Allegan-Based Firm's Tablets Had Metal Shavings

Metal shavings found in ibuprofen tablets are among four significant violations the Food and Drug Administration has found at Allegan-based Perrigo Co., a generic drug developer.

The violations were outlined in a warning letter sent to the company April 29 and posted on the FDA Web site Tuesday. Perrigo, the largest U.S. maker of store-brand over-the-counter drugs, had 15 working dates from April 29 to comply.

Arthur Shannon, Perrigo spokesman, said the company sent its response to the FDA last week.

"We are continuing to work with the FDA to ensure corrective actions are in order and approved in all areas of the investigation," Shannon said via e-mail.

Shannon addressed only the ibuprofen contaminated by the metal shavings, saying the medication "was pulled from the retail warehouse prior to reaching retail store shelves and consumers."

The warning letter details violations found during a Nov. 17-Jan. 14 inspection. Among them:

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.

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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.

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

FDA: Allegan-Based Firm's Tablets Had Metal ShavingsOriginally from: http://www.nursinglink.monster.com/news/articles/13043-fda-allegan-based-firms-tablets-had-metal-shavings

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