Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-02.
At a glance
Inspections
10
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Mar 2025 – 2 Apr 2025 | Human Drugs | 483 | View 483 → |
| 5 Dec 2017 – 8 Jan 2018 | Human Drugs | 483 | View 483 → |
| 29 Sep 2016 – 20 Oct 2016 | Human Drugs | WL | View 483 → |
| 7 Apr 2016 – 14 Apr 2016 | Human Drugs | 483 | On file |
| 19 Sep 2012 | Not recorded | 483 | View 483 → |
| 21 Aug 2012 | Not recorded | 483 | View 483 → |
| 18 May 2011 | Not recorded | Clean | |
| 30 Oct 2009 | Not recorded | Clean | |
| 22 Jan 2007 | Not recorded | Clean | |
| 1 May 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Janet A Rajan, Alisha B Patel
2 Apr 2025
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Janet A Rajan, Alisha B Patel
2 Apr 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Janet A Rajan, Alisha B Patel
Investigators
FDA investigators tied to this site in the record.
Maria Estrella2 insp.
Janet A Rajan1 insp.
Alisha B Patel1 insp.
Guerlain Ulysse1 insp.
James R Birkenstamm1 insp.
Esteban Beltran1 insp.
Gobiga Vanniyasingam1 insp.
Barbara J Wilimczyk-Macri1 insp.
Frederick Razzaghi1 insp.
Nicholas A Violand1 insp.
Anna M Brannen1 insp.
Meredith L Sheridan1 insp.
Addam S Reynolds1 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 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Raritan Pharmaceuticals, Inc.'s 6 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