FDA 483 - Milbar Laboratories, Inc. - October 11, 2019

Milbar Laboratories, Inc. in East Haven, CT, was inspected from 9/23/2019 to 10/11/2019, revealing significant deficiencies in its manufacturing and quality control systems for OTC drug products. Repeated observations from previous inspections highlight a systemic failure to establish and follow written procedures for equipment cleaning, process validation, data integrity, and complaint investigations. The firm also failed to properly calibrate equipment, validate test methods, and maintain adequate control over raw materials and computer systems.