Milbar Laboratories, Inc. – FDA 483, Nov 7, 2024

Milbar Laboratories, Inc. in East Haven, CT, a manufacturer of OTC drug products, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate stability testing practices, poor facility and equipment maintenance leading to potential contamination, and insufficient quality control oversight. These issues indicate a lack of robust controls to ensure the quality, safety, and purity of their drug products.