Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-30.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2019 – 30 Aug 2019 | Human Drugs | Clean | |
| 28 Nov 2016 – 2 Dec 2016 | Human Drugs | 483 | View 483 → |
| 16 Jun 2014 – 20 Jun 2014 | Human Drugs | 483 | View 483 → |
| 8 Nov 2011 | Not recorded | 483 | On file |
| 4 Jul 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Dec 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Toyin B Oladimeji
Investigators
FDA investigators tied to this site in the record.
Nicholas L Hunt1 insp.
Toyin B Oladimeji1 insp.
Libia M Lugo1 insp.
Charisse K Green1 insp.
Kenneth M Gordon1 insp.
Mark W Rivero1 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 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aesica Pharmaceuticals GmbH's 3 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