PharmPak, Inc. – FDA 483, Dec 9, 2021

PharmPak, Inc. in San Rafael, CA, a repackager/relabeler, was inspected by the FDA from December 1-9, 2021. The inspection revealed significant and repeat deficiencies across multiple areas, including inadequate validation of test methods and equipment, lack of proper air handling systems, and failure to establish and follow written procedures for cleaning, maintenance, quality control, and annual product reviews. These issues indicate a systemic lack of adherence to good manufacturing practices for drug products.