Diamond Wipes Gets 483 for Ignoring Quality Control Unit

A project manager at Diamond Wipes’ Chino, Calif., facility bypassed its quality control unit and allowed products deemed unfit for release to be shipped for sale anyway, a Form 483 states. In separate instances in April and May of 2011, lots of anti-bacterial drug wipes were shipped to customers despite the products having been tested out of specification (OOS) and set aside for destruction, a week-long October investigation found. In both instances, a note had been attached to the drug lots noting their acceptable use “as a regular wet wipe” in the Chino plant’s kitchen. However, in at least one instance, a project manager indicated the product was “OK to release per corporate decision — export to Mexico.” The noted OOS lots were shipped to customers in June 2011, the FDA said.
Drug GMP Report