Vaccine Maker Panacea Biotec Gets Form 483 for Poor Aseptic Techniques

Panacea Biotec, a maker of generic and specialty pharmaceuticals as well as vaccines, got rapped with a nine-observation Form 483 for inadequate oversight of aseptic procedures and environmental conditions for sterile drugs and poor training of employees, among other lapses.

During their Oct. 2-3 inspection of the company’s Himachal Pradesh facility, investigators observed an aseptic operator prying off a cover “resulting in the forceps contacting the opening of the batch tank” and the use of peeling tape for identification in the manufacturing process.

The company did not validate the aseptic process, the investigators said, having inadequate smoke studies, and did not “thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed.”

Further, investigators reported that the quality unit’s responsibilities and procedures aren’t in writing.

Read the 483 form here.

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