Omega Tech Labs, LLC
FDA inspection history across 2 sites, 2008 to 2024
- 2
- Warning letters
- 2
- Form 483s
Every document, by year
- Warning letter
- Form 483
2008: one warning letter; 2016: one Form 483; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One warning letter, at Boise, Idaho.
- 2016One Form 483, at Garden City, Idaho.
- 2016The longest 483 on file: 9 observations over 6 pages at Garden City, Idaho.
- 2024One warning letter and one Form 483, at Boise, Idaho.
Cited most
Across all Omega Tech Labs observations on file
- 21 CFR 211.113(a)Control of microbiological contamination2
- 21 CFR 211.67(b)Equipment cleaning and maintenance2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.122(d)Materials examination and usage criteria1
- 21 CFR 211.125(a)Labeling issuance1
The complete Omega Tech Labs file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Boise, Idaho
Two warning letters and one Form 483 · 2008 to 2024 · 6 observations
Latest: Warning letter, Jul 23, 2024 →Garden City, Idaho
One Form 483 · 2016 · 9 observations
Latest: Form 483, Aug 25, 2016 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-23 | Warning letter Warning letter | Boise, Idaho | — | $99 |
| 2024-01-22 | 483 Form 483 | Boise, Idaho | 6 | $99 |
| 2016-08-25 | 483 Form 483 | Garden City, Idaho | 9 | $99 |
| 2008-10-21 | Warning letter Warning letter | Boise, Idaho | — | $99 |
Investigators on these documents
FEI number 3005274476 · most recent document Jul 23, 2024
About Omega Tech Labs, LLC
How many FDA Form 483s has Omega Tech Labs, LLC received?
FDA Intel has 2 Form 483s on file for Omega Tech Labs, LLC; the most recent is dated Jan 22, 2024.
When was Omega Tech Labs, LLC last inspected by FDA?
The most recent FDA inspection document on file for Omega Tech Labs, LLC is a Form 483 dated Jan 22, 2024, for the site in Boise, Idaho.
What did FDA cite at Omega Tech Labs, LLC?
The regulations cited most in the observations on file for Omega Tech Labs, LLC are 21 CFR 211.113(a) (Control of microbiological contamination), 2 times; 21 CFR 211.67(b) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.
Has Omega Tech Labs, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Omega Tech Labs, LLC; the most recent is dated Jul 23, 2024.