FDA 483 - Parker Laboratories, Inc. - June 14, 2023

Parker Laboratories, Inc. in Fairfield, NJ, a drug manufacturing facility, was inspected by the FDA from May 24 to June 14, 2023. The inspection revealed significant deficiencies in quality control and manufacturing processes for OTC drug products, including a lack of stability testing programs, inadequate batch production records, unqualified equipment, and insufficient annual quality reviews and raw material identity testing. These observations indicate a failure to ensure the identity, strength, purity, and quality of their drug products.