FDA Cites New York Drugmaker for Flawed Investigations, Maintenance

April 15, 2019

Sterile drugmaker Unither Manufacturing drew a Form 483 for quality deficiencies at its Rochester, New York facility, including investigations of out-of-specification results.

The agency, which inspected the facility from Dec. 11-21, 2018, cited the company’s failure to fully review all unexplained discrepancies. Specifically, seven OOS results from 2017 obtained during media fill environmental monitoring were not completely investigated to find the root cause, and the firm failed to take corrective or preventive actions. The OOS results included bacterial contamination, including staphylococcus.

The investigator also found that the firm didn’t conduct dynamic smoke studies for all equipment and components to prove the air flow patterns of critical areas — such as an ISO 7 compounding room and a filling room — were suitable for aseptic operations conducted during the filling of vials of an ANDA drug product.

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