Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-15.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 May 2024 – 15 May 2024 | Human Drugs | 483 | View 483 → |
| 18 Apr 2016 – 21 Apr 2016 | Human Drugs | Clean | |
| 5 Mar 2014 – 14 Mar 2014 | Human Drugs | Clean | |
| 11 Feb 2013 – 14 Feb 2013 | Human Drugs | Clean | |
| 5 May 2011 | Not recorded | 483 | View 483 → |
| 11 Jan 2010 | Not recorded | Clean | |
| 4 Mar 2004 | Not recorded | Clean | |
| 26 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Amy N Chen, Yoriann M Cabrera Bartolomei
15 May 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Amy N Chen, Yoriann M Cabrera Bartolomei
15 May 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Amy N Chen, Yoriann M Cabrera Bartolomei
Investigators
FDA investigators tied to this site in the record.
Paul L Bellamy3 insp.
Amy N Chen1 insp.
Yoriann M Cabrera Bartolomei1 insp.
Devon Jenkins1 insp.
Darren S Morgan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AAA Pharmaceutical, Inc.'s 2 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