The FDA has posted its warning letter about APP Pharmaceuticals' New York plant, and the citations aren't pretty: Agency inspectors cited insects found in the drug production area, not to mention in several drug vials, including one that made its way into distribution. The letter is the latest in a series of missives sent by the agency detailing manufacturing lapses at a host of drugmakers.
The FDA says APP ($APPX) failed to fully correct violations at the Grand Island, N.Y., plant, after agency inspectors detailed their findings. According to the agency, the company didn't properly investigate batch failures, had inadequate written procedures for preventing bacterial contamination and for ensuring that its drugs conform to strength, purity and quality standards. The letter also cites failures to document "major defects" in drug lots, including vials found to contain particles or foreign matter.
Inspectors also discovered APP was making 5 drugs that hadn't been FDA-approved, the letter states. The drugs are older products that had been grandfathered in and weren't required to be approved until 2006. Since then, the agency has been tracking down certain unapproved products and requiring manufacturers to obtain approvals.
Insects were last found at the APP facility in March 2011, in-Pharma Technologist reports, and Fresenius says it "has made significant progress in collaboration with the FDA in remedying these issues." An APP spokesman told the Buffalo News the company has already submitted an approval application for one of the 5 unapproved meds, and the rest of the filings will be forthcoming. "APP has committed to the FDA that it will submit the necessary documentation," the spokesman said.