FDA Warns DanChem Over Contaminated APIs

The FDA has issued a warning letter to custom chemical company DanChem for failing to meet current good manufacturing practices (cGMPs) in its production of active pharmaceutical ingredients (APIs).

The warning letter stemmed from inspections of the company's Danville, Va., manufacturing plant in September and October 2004.

"The inspections documented the interstate shipment of at least seven lots of calcium polycarbophil active pharmaceutical ingredient which your customer's analyses demonstrated were contaminated with physical filth causing them to be adulterated," the FDA wrote.

DanChem submitted a response to the FDA in October 2004, but the agency deemed the response inadequate. The agency ordered DanChem to comment on the types of OOS lots that will be eligible for reprocessing in the future and on how those lots will be utilized. The agency also asked DanChem to comment on the actions it will take to prevent foreign matter from entering APIs during manufacturing.

"We are not convinced you can prevent such occurrences again until your company has identified how and why this foreign matter was introduced during manufacturing," the FDA wrote. The agency asked DanChem to submit a response within 15 work days of receiving the letter. To view the letter, go to http://www.fda.gov/foi/warning_letters/g5216d.htm (http://www.fda.gov/foi/warning_letters/g5216d.htm).