Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-16.
At a glance
Inspections
11
Form 483s
5
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2025 – 16 Sep 2025 | Human Drugs | 483 | View 483 → |
| 10 Oct 2023 – 13 Oct 2023 | Human Drugs | Clean | |
| 12 Nov 2018 – 13 Dec 2018 | Human Drugs | Clean | |
| 21 May 2018 – 25 May 2018 | Animal Drugs & Feeds | 483 | View 483 → |
| 9 May 2017 – 16 May 2017 | Human Drugs | 483 | On file |
| 10 Mar 2014 – 18 Mar 2014 | Human Drugs | 483 | View 483 → |
| 20 Sep 2011 | Not recorded | 483 | View 483 → |
| 29 Apr 2010 | Not recorded | Clean | |
| 17 Sep 2008 | Not recorded | Clean | |
| 11 Jul 2003 | Not recorded | Clean | |
| 9 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Sep 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Justin A Boyd, Vivin George, Karen A Briggs
16 Sep 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Vivin George, Karen A Briggs
16 Sep 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Vivin George, Karen A Briggs
16 Sep 2025
21 CFR 211.186(a)
Written procedures followed
Cited by Justin A Boyd, Vivin George, Karen A Briggs
16 Sep 2025
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Justin A Boyd, Vivin George, Karen A Briggs
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Vivin George1 insp.
Karen A Briggs1 insp.
MRA B KambereM1 insp.
MRA DavisM1 insp.
Taichun Qin1 insp.
Jose A Cruz Gonzalez1 insp.
Debra M Emerson1 insp.
Jeremy W Rotton1 insp.
Russell J Glapion1 insp.
Shirley J Berryman1 insp.
Azza Talaat1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fareva Amboise's 5 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