Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2020-02-18.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Feb 2020 – 18 Feb 2020 | Human Drugs | Clean | |
| 11 Dec 2014 – 12 Dec 2014 | Human Drugs | 483 | View 483 → |
| 14 Feb 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Dec 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Victoria A Wagoner, Kim L Thomas Cruse
12 Dec 2014
21 CFR 211.68(b)
Computer control of master formula records
Cited by Victoria A Wagoner, Kim L Thomas Cruse
12 Dec 2014
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Victoria A Wagoner, Kim L Thomas Cruse
12 Dec 2014
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Victoria A Wagoner, Kim L Thomas Cruse
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Evonik Operations 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