FDA 483 - Calvin Scott & Company, Inc. - June 18, 2021

Calvin Scott & Company, Inc. in Albuquerque, NM, a drug repacker and relabeler, received a Form 483 with seven observations, including several repeat observations from a previous inspection. The inspection revealed significant deficiencies in quality control, equipment qualification, employee training, facility sanitation, and process validation. These issues indicate a lack of adherence to cGMP requirements for drug product repackaging, posing potential risks to product quality and patient safety.