The QMN Weekly Bulletin

Insects, Quality Control Issues Prompt 483 for Fresenius Kabi

April 19, 2013

Fresenius Kabi USA received a Form 483 for some persistent pests at the company’s Grand Island, N.Y., facility and for not following quality control procedures.

During an inspection in December and January, the agency investigation uncovered internal records revealing insects in the sterile manufacturing facility and inside the vials of finished drug products from August 2011 to as recently as October 2012.

In one report, a centipede was discovered in a vial of lidocaine HCL during a visual inspection process. In another, a live spider was found on the floor of the aseptic preparation gowning area, the FDA said.

The agency cited a similar observation during an inspection in July 2011.

“These persistent deviations indicate that your implemented action to mitigate the infiltration of insects into the plant environment are inadequate,” the FDA said.

FDA investigators also noted Fresenius fails to follow its own quality control procedures.

Specifically, the firm’s quality control unit approved releasing lots of sterile finished drug products prior to closing an investigation into fungal excursions in aseptic manufacturing areas, the form states.

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