Pemco received a Form 483 when inspectors found it had not submitted timely correction and removal and MDR reports, and had committed other violations.

FDA inspectors visited Pemco’s Independence, Ohio, facility in October 2016 and found that a report on device correction and removal actions was not sent to the FDA within 10 days of initiating the correction or removal.

Specifically, after a retractor device was returned for service on May 14, 2013, Pemco found the cover plates were improperly heat-treated and contaminated with carbon. It concluded that a removal would be performed but did not submit the correction/removal to the FDA until June 27, 2013.

In other listed problems, the inspectors found that non-conforming products were not adequately controlled. The company initiated Nonconforming Product Reports for undersized and oversized extender bar adapters, but the report was unclear about how many products were actually non-conforming, which products were approved for rework, and if all non-conforming products were accounted for.

Pemco also failed to document which testing equipment was used when measuring dimensional specifications and had not validated its cleaning processes for finished devices. — Jeff Kinney