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

Source: https://www.keypedia.com/records/483/omega-tech-labs-llc/1b25e14c-91fe-4815-85b9-bbb9dc8e5536

> FDA 483 for Omega Tech Labs, LLC on January 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega Tech Labs, LLC
- Inspection Date: 2024-01-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Documents

- [483 - 2025-07-30](https://www.keypedia.com/records/483/omega-tech-labs-llc/f7bb4324-1472-47ee-b738-1a78e4a9e281)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/omega-tech-labs-llc/85cf5888-6344-4179-9b59-4610833d6f11

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822