Omega Tech Labs, LLC
Form 483 issued January 22, 2024 · Boise, Idaho
- Inspection
- Jan 17 – Jan 22, 2024
- Investigator
- Bryan L. McGuckin
- Observations
- 6
- Pages
- 7
- FEI number
- 3005274476
In short: On January 22, 2024, FDA issued a Form 483 with 6 observations to Omega Tech Labs, LLC in Boise, Idaho (FEI 3005274476) after an inspection that ran Jan 17 – Jan 22, 2024. The investigator was Bryan L. McGuckin. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Records are not kept for the maintenance, cleaning…
- 04
The identity of each component of a drug product is not verified by conducting at least…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmOmega Tech Labs, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Omega Tech Labs, LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Omega Tech Labs, LLC?
Bryan L. McGuckin is named on this Form 483, for the inspection of Jan 17 – Jan 22, 2024. Each investigator has a profile showing what they cite most.
When was Omega Tech Labs, LLC inspected by FDA?
The inspection ran Jan 17 – Jan 22, 2024, and the Form 483 is dated January 22, 2024.
How do I get the full Form 483 for Omega Tech Labs, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.