Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-12-18.
At a glance
Inspections
5
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Dec 2015 – 18 Dec 2015 | Human Drugs | 483 | View 483 → |
| 15 Dec 2014 – 19 Dec 2014 | Human Drugs | 483 | View 483 → |
| 5 Mar 2013 – 28 Mar 2013 | Human Drugs | 483 | On file |
| 19 Aug 2011 | Not recorded | Clean | |
| 29 Jun 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Dec 2015
21 CFR 211.122(e)
Destruction of obsolete labeling
Cited by Cheryl A Clausen, Dell S Moller
18 Dec 2015
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Cheryl A Clausen, Dell S Moller
18 Dec 2015
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Cheryl A Clausen, Dell S Moller
18 Dec 2015
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Cheryl A Clausen, Dell S Moller
Investigators
FDA investigators tied to this site in the record.
Rachel C Harrington2 insp.
Cheryl A Clausen1 insp.
Dell S Moller1 insp.
Toyin B Oladimeji1 insp.
Eric L Dong1 insp.
Chiang Syin1 insp.
Ernest Bizjak1 insp.
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 | 2x |
| 21 CFR 211.122(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American Antibiotics, Inc.'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