FDA Warning Letter issued to US Manufacturer of non-sterile Drugs

 On July 23, the FDA issued a Warning Letter to Omega Tech Labs LLC in Boise, USA, citing several deficiencies:

1. Written Procedures: Omega lacked proper procedures to prevent contamination in non-sterile products, releasing items after using preservatives and retesting without investigating the contamination source. The FDA requires a comprehensive review of processes, contamination risks, batch investigations, and definition of microbiological release specifications.

2. Production and Process Control: The company did not validate production processes or the water system used. The FDA demands assessment and remediation of the water system, process validation plans, and improved cleaning validation.

3. Testing of Raw Materials: Inadequate testing of raw materials, particularly glycerine, was noted. The FDA calls for a review of material systems, test descriptions, and risk assessments for contamination.

4. Stability Data: Insufficient stability data for product shelf life requires an enhanced stability program.

5. Quality Control: Inadequate investigation of deviations and test results necessitates a remediation plan and additional resources for the quality control department.