Controls Found Lacking at Contract Manufacturer

December 13, 2018

Contract manufacturer Thatcher Company failed to exercise appropriate controls over computers and related systems to assure that changes in production were only instituted by authorized personnel, FDA inspectors found during a Sept 10 to Sept. 18 inspection of the firm’s Salt Lake City, Utah, facility.

The inspector reviewed data for certain PCMX Scrub products and found 52 events listed as a deleted result.

The firm’s quality director and a lab analyst were “unable to explain what ‘deleted result’ meant and they were unable to provide records or documentation explaining the events,” the 483 said.

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