# FDA WARNING_LETTER - Omega Tech Labs LLC - January 22, 2024

Source: https://www.keypedia.com/records/warning_letter/omega-tech-labs-llc/c8e71f03-445f-4098-a0ee-3e66d5bdee3e

> FDA WARNING_LETTER for Omega Tech Labs LLC on January 22, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Omega Tech Labs LLC
- Inspection Date: 2024-01-22
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/omega-tech-labs-llc/c64985b5-a2b2-4fd5-8f13-c94a3701b986

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6