FDA 483 - Omega Tech Labs, LLC - January 22, 2024

Omega Tech Labs, LLC, a drug manufacturer in Boise, ID, was inspected by the FDA from January 17-22, 2024. The inspection revealed significant deficiencies across multiple areas, including inadequate procedures for preventing microbiological contamination, lack of qualification and validation for water systems and equipment, insufficient record-keeping, and failures in quality control unit responsibilities. These issues indicate a broad lack of adherence to current good manufacturing practices, posing potential risks to drug product quality and safety.