Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-07-06.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jul 2017 – 6 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Dec 2014 – 12 Dec 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Jul 2017
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Donna L Besone
6 Jul 2017
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Donna L Besone
Investigators
FDA investigators tied to this site in the record.
Donna L Besone1 insp.
Ralph W Jerndal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind GAMBRO ROSTOCK GMBH's 1 Form 483
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