FDA EIR - Acupac Packaging Inc - December 17, 2018

An FDA inspection of Acupac Packaging Inc. was conducted from December 12 to 17, 2018, at their Mahwah, New Jersey facility. The company operates as a contract primary and secondary packer for prescription and OTC drug products, cosmetics, and medical devices, and has recently begun manufacturing prescription drugs. This surveillance inspection focused on the firm's Quality, Facilities and Equipment, and Laboratory Control Systems. It was performed under guidance from CP 7356.002B, relating to Drug Manufacturing Inspections for Repackers and Relabelers, ensuring adherence to established good manufacturing practices. The review encompassed Standard Operating Procedures, training records, deviation management, complaint handling, preventative maintenance, calibration records, and equipment qualification. Notably, the inspection concluded without any observations of objectionable conditions or deficiencies. Consequently, no Form FDA-483, Inspectional Observations, was issued, and no samples were collected. This outcome indicates that Acupac Packaging Inc. was found to be operating in compliance with regulatory standards during this period, and no specific corrective actions were required by the FDA.