FDA 483 - Appco Pharma LLC - November 06, 2018

Appco Pharmaceuticals LLC in Piscataway, NJ, was inspected from October 25 to November 6, 2018, revealing significant deficiencies in their facilities and equipment systems. The inspection cited issues with the appropriate design, location, and calibration of analytical balances and a check-weigher machine. These findings indicate a lack of adequate control over critical manufacturing equipment, which could impact product quality and data integrity.