FDA 483 - Omega Alpha Pharmaceuticals - February 24, 2022

Omega Alpha Pharmaceuticals, a dietary supplement manufacturer in Scarborough, was inspected by the FDA and received a Form 483. The inspection revealed significant issues including inadequate pest control, non-compliance with acidified and low-acid canned food regulations, and multiple deficiencies in dietary supplement manufacturing records and quality control testing. These observations indicate potential insanitary conditions and a lack of adherence to regulatory requirements for both food and dietary supplement production.