Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-23.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 23 Jan 2025 | Human Drugs | 483 | View 483 → |
| 15 Aug 2022 – 25 Aug 2022 | Human Drugs | 483 | View 483 → |
| 9 Apr 2019 – 2 May 2019 | Human Drugs | WL | View 483 → |
| 5 Sep 2017 – 19 Sep 2017 | Human Drugs | 483 | View 483 → |
| 6 Jan 2016 – 1 Feb 2016 | Human Drugs | 483 | View 483 → |
| 22 Feb 2013 – 4 Mar 2013 | Human Drugs | 483 | View 483 → |
| 21 Apr 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Jan 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Mindy M Chou, Kara J Wright, Lu Chen
23 Jan 2025
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Mindy M Chou, Kara J Wright, Lu Chen
23 Jan 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Mindy M Chou, Kara J Wright, Lu Chen
23 Jan 2025
21 CFR 211.166(a)
Written program not followed
Cited by Mindy M Chou, Kara J Wright, Lu Chen
Investigators
FDA investigators tied to this site in the record.
James R Birkenstamm2 insp.
Mindy M Chou1 insp.
Kara J Wright1 insp.
Lu Chen1 insp.
Ko U Min1 insp.
Adetutu M Gidado1 insp.
Nancy M Espinal1 insp.
Barbara J Wilimczyk-Macri1 insp.
Frederick Razzaghi1 insp.
Lauren L Vajo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind A.P. Deauville, LLC's 7 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