Pennsylvania Generics Facility Receives 483 for Quality Failures

December 30, 2021

FDA investigators observed numerous quality failures during an inspection of a KVK Tech generic drug manufacturing facility in Newton, Penn., ranging from lax cleaning to incomplete investigations of complaints.

In the eight-observation Form 483 inspection report, the agency investigators observed that the facility investigated individual complaints concerning its oxycodone products, but did not extend those investigations to include other potentially impacted products.

The agency officials also observed problems with the physical plant. The production room, for example, had reoccurring roof leaks that impacted two batches of drug product, and the company failed to implement a corrective and preventive action (CAPA) by the assigned date.

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