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

An FDA inspection conducted at Omega Tech Labs, LLC from January 17-22, 2024, identified significant deficiencies in their manufacturing and quality control processes. The inspection revealed that the company lacked adequate procedures to prevent microbial contamination in non-sterile drug products, as evidenced by the release of multiple finished product lots that failed microbial testing. Further issues included an unqualified water system repeatedly failing microbial specifications, with insufficient documentation for modifications, sanitization, and routine maintenance. Production equipment, such as mixers and filling lines, also lacked qualification, and there was an absence of validation data for both veterinary and human drug products, as well as stability data to support product expiration dates. The company failed to maintain comprehensive records for equipment cleaning and sanitization, and its cleaning validation was outdated. Identity testing for raw material components, such as Glycerol/Glycerin, was not performed before use. The Quality Control Unit was found to be non-compliant with its own procedures, failing to conduct formal investigations into microbial failures and neglecting required water quality tests. A repeat observation noted inadequate control over access to labels and labeling materials. These findings indicate a failure to adhere to the Federal Food, Drug, and Cosmetic Act's requirements for drug manufacturing. Omega Tech Labs, LLC is expected to submit a detailed response outlining comprehensive corrective actions to address these serious observations and ensure compliance with regulatory standards.