Omega Tech Labs LLC – FDA Warning Letter, Jan 22, 2024

The FDA inspected Omega Tech Labs LLC's drug manufacturing facility in Boise, ID, from January 17-22, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for their combination product, (b)(4), and other drug products. The combination product is deemed adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, (b)(4) was previously cited as an unapproved new drug.

Key violations include: 1. **Failure to prevent objectionable microorganisms (21 CFR 211.113(a)):** The firm released batches exceeding microbial limits, using preservatives to reduce counts instead of proper manufacturing practices. Water used in manufacturing also exceeded microbial limits and was not tested for objectionable organisms. 2. **Inadequate production and process controls (21 CFR 211.100(a)):** The firm lacked validation data for the manufacturing process and equipment, failed to evaluate cleaning procedures after new product introduction, and lacked qualification/maintenance documentation for their water system. 3. **Inadequate raw material testing (21 CFR 211.84(d)(1) and 221.84(d)(2)):** The firm did not adequately test incoming raw materials, including high-risk components like glycerin, relying on supplier reports without validation. 4. **In