Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-03.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 May 2026 – 3 Jun 2026 | Human Drugs | 483 | View 483 → |
| 26 Aug 2024 – 6 Sep 2024 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Sep 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
6 Sep 2024
21 CFR 211.180(c)
Records not made readily available to FDA
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
6 Sep 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tekalign Wondimu, Yaharn Su, Kara J Wright
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Annovex Pharma, Inc.'s 2 Form 483s
Source PDFs 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