FDA upgrades Fresenius sterile plant once cited for insect infestation

A Fresenius Kabi sterile manufacturing plant in New York that the FDA cited in 2012 after finding insects in some of the drug vials has earned a reprieve from the agency. The drugmaker said Tuesday that the FDA will allow the APP Pharmaceuticals plant to seek approvals for drugs manufactured there.

The Germany-based drugmaker announced Tuesday that the FDA has upgraded the status of the facility to voluntary action indicated (VAI) from the previous designation of official action indicated, the company said. The new status came after an inspection in October.

"The new VAI classification permits FDA approval of new Fresenius Kabi products at the plant," the drugmaker said.

The facility in Grand Island, NY, was written up in a warning letter in February 2012 for a long list of issues, including the insect infestation that the drugmaker believed was introduced by the manufacturer of vial stoppers used at the time. Maybe so, the FDA said, but it questioned why it took Fresenius 16 months to audit the stoppermaker. The warning letter also raised questions about heparin manufacturing at that plant, saying that the agency was concerned about what it called a "a trend" of out of specification assay results for batches of its heparin active pharmaceutical ingredient (API) and Lock Flush. The agency made the facility audit three years of results for the heparin manufactured there.

On Tuesday, the drugmaker said, "The status change reflects the improvements that have been made at the plant since receiving a warning letter in 2012. Fresenius Kabi remains committed to continuous improvement and compliance in its operations worldwide."

It is dealing with some of other issues in its "worldwide" operations. A plant in India was issued an FDA warning letter in July 2013 for problems that included employees lying about having blended APIs that failed quality tests into batches that passed in an effort to hit specifications. The warning letter also said employees at the facility confessed that during the January inspection and previous inspections, high-pressure liquid chromatography equipment and personnel computers were removed from the plant to "conceal data manipulations."

- here's the announcement

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