The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Inspections and Audits / Postmarket Safety

Sterile Drugmaker Receives 483 for Lax Investigations

Dec. 20, 2013

Sloppy investigations into various deviations such as hair in finished drug vials are outlined by the FDA in a Form 483 for OSO Biopharmaceuticals Manufacturing.

During an August inspection of the company’s Albuquerque, N.M., facility, the agency found records of a vial with hair wrapped around the stopper and partially in the vial. OSO’s deviation report noted that trends found during investigations do not require preventive action.

The agency also rapped OOS for six aseptic breaks observed during product leaking that stemmed from faulty clamps, loose clamps and too-tightened clamps, the form reads. “There were no preventative actions or follow-up,” the FDA said.

The FDA also observed out-of-specification results of samples from May 2012 to November 2012. While OSO attributed the issue to dirty glassware, there were no adequate corrective and preventive actions taken and the issue continued without resolution, the five-observation form reads.

There is also no documentation of any employees receiving recent training.

Secrets of FDA Drug and Biologics Inspection Preparation contains everything you need to know to avoid getting a 483 yourself. Learn the FDA’s secrets. Now you know how it’s done.