Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-16.
At a glance
Inspections
5
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2022 – 16 Sep 2022 | Human Drugs | 483 | View 483 → |
| 11 Mar 2020 – 12 Mar 2020 | Human Drugs | Clean | |
| 19 Aug 2019 – 28 Aug 2019 | Human Drugs | 483 | View 483 → |
| 5 Dec 2017 – 13 Dec 2017 | Human Drugs | 483 | View 483 → |
| 26 Aug 2014 – 3 Sep 2014 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Sep 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Junho Pak, Syeda N Mahazabin
Investigators
FDA investigators tied to this site in the record.
Junho Pak1 insp.
Syeda N Mahazabin1 insp.
Patric C Klotzbuecher1 insp.
Tonia F Bernard1 insp.
Rachael A Moliver1 insp.
James D Bridges1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | 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)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Athenex Pharma Solutions, LLC's 3 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