Overview
- 17 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-22.
At a glance
Inspections
17
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Sep 2022 – 22 Sep 2022 | Human Drugs | 483 | View 483 → |
| 21 Feb 2018 – 12 Mar 2018 | Human Drugs | 483 | View 483 → |
| 19 Apr 2017 – 11 May 2017 | Human Drugs | 483 | View 483 → |
| 21 Oct 2014 – 3 Nov 2014 | Human Drugs | 483 | View 483 → |
| 10 Jun 2013 – 18 Jun 2013 | Human Drugs | 483 | View 483 → |
| 9 Feb 2012 | Not recorded | Clean | |
| 2 Feb 2011 | Not recorded | 483 | View 483 → |
| 1 Sep 2010 | Not recorded | 483 | View 483 → |
| 11 Sep 2009 | Not recorded | 483 | On file |
| 14 May 2008 | Not recorded | 483 | On file |
| 11 May 2007 | Not recorded | Clean | |
| 28 Feb 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Sep 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Bryan A Galvez, Claudia M Perez-Kasmarski
22 Sep 2022
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Bryan A Galvez, Claudia M Perez-Kasmarski
22 Sep 2022
21 CFR 211.194(a)
Complete test data included in records
Cited by Bryan A Galvez, Claudia M Perez-Kasmarski
22 Sep 2022
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Bryan A Galvez, Claudia M Perez-Kasmarski
22 Sep 2022
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Bryan A Galvez, Claudia M Perez-Kasmarski
Investigators
FDA investigators tied to this site in the record.
Joey V Quitania4 insp.
Jennifer M Gogley3 insp.
Linda Thai3 insp.
Caryn M Mcnab3 insp.
Bryan A Galvez1 insp.
Claudia M Perez-Kasmarski1 insp.
Carrie A Hughes1 insp.
William J Leonard1 insp.
Yasamin Ameri1 insp.
Paul A Bonneau1 insp.
Carla J Lundi1 insp.
Angele C Smith1 insp.
Nelly N Tran1 insp.
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 | 10x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | 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 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.48(a) | 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)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PrimaPharma Inc's 9 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