Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-09-15.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | 483 | View 483 → |
| 8 Feb 2016 – 11 Feb 2016 | Human Drugs | 483 | View 483 → |
| 29 Jun 2015 – 3 Jul 2015 | Human Drugs | Clean | |
| 18 Feb 2013 – 22 Feb 2013 | Human Drugs | 483 | View 483 → |
| 5 Nov 2010 | Not recorded | 483 | View 483 → |
| 19 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Feb 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Meisha R Sampson, Rakhi B Shah, Steven B Hertz, Meisha R Waters
11 Feb 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Meisha R Sampson, Rakhi B Shah, Steven B Hertz, Meisha R Waters
22 Feb 2013
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Anita R Michael, Marianela Aponte Cruz
Investigators
FDA investigators tied to this site in the record.
Niketa Patel1 insp.
Meisha R Sampson1 insp.
Rakhi B Shah1 insp.
Steven B Hertz1 insp.
Meisha R Waters1 insp.
Steven D Kehoe1 insp.
Anita R Michael1 insp.
Marianela Aponte Cruz1 insp.
Farhana Khan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind G. Pohl-Boskamp GmbH & Co. KG'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