FDA 483 - Milbar Laboratories, Inc. - September 27, 2022

Milbar Laboratories, Inc. in East Haven, CT, a pharmaceutical manufacturer of OTC drug products, was cited with 13 observations during an FDA inspection. The findings indicate significant deficiencies across multiple quality system areas, including a lack of process and cleaning validation, inadequate stability testing and method validation, failures in quality unit responsibilities, and insufficient controls over computer systems. Several observations were repeats from previous inspections, highlighting persistent issues.