Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-18.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2024 – 18 Jun 2024 | Human Drugs | 483 | On file |
| 25 Oct 2021 – 28 Oct 2021 | Human Drugs | Clean | |
| 12 Nov 2018 – 15 Nov 2018 | Medical Devices & Rad Health | Clean | |
| 30 May 2016 – 7 Jun 2016 | Human Drugs | Clean | |
| 7 Jul 2014 – 15 Jul 2014 | Human Drugs | 483 | View 483 → |
| 13 Sep 2011 | Not recorded | 483 | On file |
| 16 Jul 2009 | Not recorded | Clean | |
| 24 Jul 2008 | Not recorded | Clean | |
| 8 Apr 2008 | Not recorded | 483 | On file |
| 5 Mar 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2014
21 CFR 211.110(a)
Written in-process control procedures
Cited by Michael R Klapal, Nicole A Lloyd
15 Jul 2014
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Michael R Klapal, Nicole A Lloyd
15 Jul 2014
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Michael R Klapal, Nicole A Lloyd
Investigators
FDA investigators tied to this site in the record.
Lauren N Howard1 insp.
Bryan L Mcguckin1 insp.
Sarah A Hassas1 insp.
Tracey L Harris1 insp.
Michael R Klapal1 insp.
Nicole A Lloyd1 insp.
Thomas J Arista1 insp.
Stephen D Eich1 insp.
Dennis Cantellops Paite1 insp.
Carmelo Rosa1 insp.
Don H Bark1 insp.
Sharon K Thoma1 insp.
Richard L Rutherford1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pharmpur Gmbh's 4 Form 483s
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