Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-01-30.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2018 – 30 Jan 2018 | Human Drugs | 483 | View 483 → |
| 23 Jun 2016 – 1 Jul 2016 | Human Drugs | 483 | View 483 → |
| 17 Nov 2014 – 25 Nov 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jan 2018
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Djamila Harouaka, Qin Xu
30 Jan 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Djamila Harouaka, Qin Xu
1 Jul 2016
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Frank Wackes, Paul A Bonneau
Investigators
FDA investigators tied to this site in the record.
Djamila Harouaka1 insp.
Qin Xu1 insp.
Frank Wackes1 insp.
Paul A Bonneau1 insp.
Steven Fong1 insp.
Denise M Digiulio1 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 | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.12(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GP Grenzach Produktions GmbH's 3 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