Overview
- 26 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-08.
At a glance
Inspections
26
Form 483s
10
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Nov 2023 – 8 Dec 2023 | Human Drugs | Clean | |
| 18 Jul 2022 – 10 Aug 2022 | Human Drugs | 483 | View 483 → |
| 17 Jul 2019 – 8 Aug 2019 | Animal Drugs & Feeds | 483 | View 483 → |
| 17 May 2018 – 29 May 2018 | Human Drugs | 483 | View 483 → |
| 19 Oct 2016 – 10 Nov 2016 | Human Drugs | Clean | |
| 3 Dec 2014 – 23 Dec 2014 | Human Drugs | 483 | On file |
| 23 Oct 2013 – 31 Oct 2013 | Human Drugs | 483 | View 483 → |
| 16 Nov 2012 | Not recorded | 483 | View 483 → |
| 15 Jun 2012 | Not recorded | 483 | View 483 → |
| 9 Feb 2011 | Not recorded | 483 | View 483 → |
| 12 Jan 2010 | Not recorded | 483 | View 483 → |
| 6 Feb 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Aug 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Bijoy Panicker, Amatul H Marium, Karishma G Gopaul
10 Aug 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Bijoy Panicker, Amatul H Marium, Karishma G Gopaul
10 Aug 2022
21 CFR 211.165(b)
Microbiological testing
Cited by Bijoy Panicker, Amatul H Marium, Karishma G Gopaul
10 Aug 2022
21 CFR 211.165(b)
Microbiological testing
Cited by Bijoy Panicker, Amatul H Marium, Karishma G Gopaul
10 Aug 2022
21 CFR 211.94(a)
Reactive/Additive/Absorptive Containers/Closures
Cited by Bijoy Panicker, Amatul H Marium, Karishma G Gopaul
Investigators
FDA investigators tied to this site in the record.
Karishma G Gopaul2 insp.
Alice S Tsao2 insp.
Paul C Mouris2 insp.
Robert C Horan2 insp.
Uduak M Inokon2 insp.
Raihan A Chowdhury1 insp.
Bijoy Panicker1 insp.
Amatul H Marium1 insp.
Sony Mathews1 insp.
Jose O Hernandez1 insp.
Rachael A Moliver1 insp.
Mindy M Chou1 insp.
Demitria J Xiradakis1 insp.
Neil J Bonzagni1 insp.
Parul M Patel1 insp.
Dongping Dai1 insp.
Gary J Lehr1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 3x |
| 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 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | 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(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(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 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fougera Pharmaceuticals, LLC's 10 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