Sterile Compounder Lands Form 483 Over Sterility Issues

June 17, 2016

A swarm of sterility and record-keeping issues led the FDA to cite a Texas drugmaker with a 13-observation Form 483.

An inspection at Stonegate Pharmacy’s Austin, Texas-based facility revealed that none of the drug sterilization processes for testosterone, testosterone/anastrazole and estradiol pellets had been properly validated.

Aseptic processing areas also were deemed deficient in environmental monitoring. The document states that employees failed to conduct environmental monitoring of the ISO 5 area on a daily basis, and produced no documentation of when samples were taken and how they were incubated.

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