Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-30.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 30 Jul 2025 | Human Drugs | 483 | View 483 → |
| 17 Jan 2024 – 22 Jan 2024 | Human Drugs | WL | View 483 → |
| 8 Aug 2016 – 25 Aug 2016 | Human Drugs | 483 | View 483 → |
| 25 Mar 2013 – 3 Apr 2013 | Human Drugs | 483 | On file |
| 2 Oct 2009 | Not recorded | 483 | View 483 → |
| 11 Feb 2008 | Not recorded | WL |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jul 2025
21 CFR 211.166(a)
Lack of written stability program
Cited by Truong X Nguyen, Tareq W Haddad
30 Jul 2025
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Truong X Nguyen, Tareq W Haddad
Investigators
FDA investigators tied to this site in the record.
Truong X Nguyen1 insp.
Tareq W Haddad1 insp.
Bryan L Mcguckin1 insp.
Christopher R Czajka1 insp.
Lawrence Y Lee1 insp.
Barbara J Breithaupt1 insp.
Donald W Jehn1 insp.
Heika R Tait1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Omega Tech Labs, Inc.'s 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat