DETROIT—The Food and Drug Administration office in Detroit sent a warning letter to Allegan drugmaker Perrigo, saying the company did not take sufficient corrective actions following contamination of products IN 2008. It also says the company's quality control unit (QCD) failed to follow written procedures.
The letter comes after the FDA investigated the recall of Ibuprofen tablets, contaminated with metal shavings in the container, not in the tablets. The warning letter says Perrigo still shipped out some of the affected tablets in 2008. John T. Hendrickson, Executive Vice President of Perrigo's Global Operations and Supply Chain says an equipment failure caused the contamination, and the contaminated product was retrieved before it hit the shelves.
Mr. Hendrickson says Perrigo replied to the warning letter and is working with the FDA to ensure the issue is resolved. "Our number one goal is to provide safe and effective products to customers," Hendrickson says.