FDA 483 - Acupac Packaging Inc - March 14, 2025

Acupac Packaging Inc. in Mahwah, NJ, a manufacturer and repacker, was cited with two observations during an FDA inspection. The observations relate to the firm's failure to properly qualify laboratory equipment, specifically an FTIR spectroscopy instrument, and to verify the suitability of analytical testing methods used for bulk drug products. These issues indicate deficiencies in quality control and assurance practices.