Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-10.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Nov 2022 – 10 Nov 2022 | Human Drugs | 483 | View 483 → |
| 1 Dec 2015 – 4 Dec 2015 | Human Drugs | 483 | View 483 → |
| 21 May 2009 | Not recorded | Clean | |
| 17 Nov 2006 | Not recorded | Clean | |
| 30 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Nov 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
Investigators
FDA investigators tied to this site in the record.
Margaret M Annes2 insp.
Dorothy P Kramer1 insp.
Christopher N Tran1 insp.
Shawn E Larson1 insp.
Lloyd D Payne1 insp.
Loan T Tran1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PD-Rx Pharmaceuticals Inc.'s 2 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