Overview
- 20 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-01.
At a glance
Inspections
20
Form 483s
10
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jul 2024 – 1 Aug 2024 | Human Drugs | Clean | |
| 25 May 2022 – 15 Jun 2022 | Human Drugs | 483 | View 483 → |
| 8 Apr 2019 – 11 Apr 2019 | Human Drugs | 483 | View 483 → |
| 16 Mar 2017 – 30 Mar 2017 | Human Drugs | 483 | View 483 → |
| 20 Jul 2015 – 23 Jul 2015 | Human Drugs | 483 | View 483 → |
| 13 Nov 2013 – 21 Nov 2013 | Human Drugs | 483 | On file |
| 13 Mar 2013 – 4 Apr 2013 | Human Drugs | 483 | View 483 → |
| 27 Mar 2012 | Not recorded | Clean | |
| 22 Nov 2011 | Not recorded | 483 | View 483 → |
| 23 Nov 2010 | Not recorded | 483 | View 483 → |
| 10 Mar 2010 | Not recorded | 483 | View 483 → |
| 6 May 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jun 2022
21 CFR 211.101(d)
Component release checked by 2nd person
Cited by Bijoy Panicker, Brandy N Lepage
15 Jun 2022
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Bijoy Panicker, Brandy N Lepage
15 Jun 2022
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Bijoy Panicker, Brandy N Lepage
15 Jun 2022
21 CFR 211.194(a)(2)
Laboratory Test Method Verification
Cited by Bijoy Panicker, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Robert C Horan2 insp.
James A Liubicich2 insp.
Robert C Steyert2 insp.
Alice S Tsao2 insp.
Irina Gaberman2 insp.
Byungja E Marciante1 insp.
Bijoy Panicker1 insp.
Brandy N Lepage1 insp.
Karen L Kosar1 insp.
Omadevi Somai1 insp.
Jose O Hernandez1 insp.
Jay T Wong1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | 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 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | 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 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | 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)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Jerome Stevens Pharmaceuticals, Inc.'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