Ranier’s Compounding Laboratory Draws Form 483, Safety Alert Over Sterility Issues

July 12, 2018

In a follow-up inspection to a March 2017 warning letter, the FDA issued a Form 483 to Ranier’s Compounding Laboratory, accompanied by a public safety alert warning healthcare professionals and patients not to use the facility’s products purporting to be sterile.

In a May inspection of the laboratory’s Jeannette, Pennsylvania facility, FDA officials found facility personnel touched equipment outside of the aseptic processing area with gloved hands and continued aseptic processing activities without changing or sanitizing the gloves.

FDA investigators also observed personnel conducting aseptic processing with exposed hair, failing to disinfect materials or supplies before entering the aseptic processing areas after handling them with bare hands, and insufficient use of sporicidal agents in the ISO 5 classified aseptic processing area. Moreover, they further found disinfecting agents and cleaning wipes used in the same areas were not sterile, with personnel using non-sterile lint free wipes that are kept in an uncovered stack to clean and disinfect the ISO 5 hood.

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