Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-04-26.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2019 – 26 Apr 2019 | Human Drugs | 483 | View 483 → |
| 31 Jul 2017 – 4 Aug 2017 | Human Drugs | Clean | |
| 6 Jul 2015 – 10 Jul 2015 | Human Drugs | 483 | On file |
| 9 Sep 2013 – 13 Sep 2013 | Human Drugs | 483 | View 483 → |
| 15 Jul 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Carrie A Hughes1 insp.
Robert J Ham1 insp.
Zachary A Bogorad1 insp.
Philip Kreiter1 insp.
Alice S Tsao1 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 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Purdue Pharma's 4 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