FDA Form 483 Dings Florida Compounder for Recurring Problems

It was a blast from the past for Hybrid Pharmaceuticals, when FDA investigators observed the same corrosion, dust, and poor aseptic technique noted in inspections carried out in 2016, 2019 and 2021.

Smoke flow studies and media fill simulations still were not up to snuff, although they had been noted in 2016 and 2019, the investigator noted. A window on the door to one filling room didn’t close completely, impacting the suite’s positive air pressure, a problem also observed in 2019 and a validation method for the potency of injectable ascorbic acid still wasn’t adequate, even though investigators had found it problematic in 2016, 2019, and 2021.

A new problem, however, was the first on the 11-observation Form 483 handed to the Deerfield Beach, Fla., manufacturer. A HEPA filter mounted directly over a filling station had brown stains of an “unknown origin” on it, the report said. Open sterile glass vials were being filled directly below the stain, which was complemented by “approximately 25 brown spots of unknown origin on the ISO-7 buffer room ceiling HEPA filter located over the table where vial crimping takes place,” the report states.

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