Jacobus Pharmaceutical Company, Inc.
FDA inspection history across 4 sites, 2011 to 2025
- 3
- Form 483s
- 3
- EIRs
- 1
- Response
Every document, by year
- Form 483
- EIR
- Response
2011: one inspection report and one amended 483; 2012: one 483 response and one inspection report; 2013: one inspection report; 2014: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011–14Three inspection reports, one amended 483, one 483 response and one Form 483, at Plainsboro, New Jersey; Princeton, New Jersey and Plainsboro, Alabama.
- 2011The longest 483 on file: 10 observations over 12 pages at Plainsboro, New Jersey.
- 2025One Form 483, at PLAINSBORO, New Jersey.
Cited most
Across all Jacobus Pharmaceutical Company observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Jacobus Pharmaceutical Company file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Plainsboro, New Jersey
Three inspection reports and one amended 483 · 2011 to 2013 · 10 observations
Latest: EIR, Jul 15, 2013 →PLAINSBORO, New Jersey
One Form 483 · 2025 · 6 observations
Latest: Form 483, Apr 23, 2025 →Plainsboro, Alabama
One Form 483 · 2014 · 8 observations
Latest: Form 483, Jun 27, 2014 →Princeton, New Jersey
One 483 response · 2012
Latest: Response, Apr 30, 2012 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-23 | 483 Form 483 | PLAINSBORO, New Jersey | 6 | $99 |
| 2014-06-27 | 483 Form 483 | Plainsboro, Alabama | 8 | $99 |
| 2013-07-15 | EIR EIR | Plainsboro, New Jersey | — | $550 |
| 2012-04-30 | Response 483 response | Princeton, New Jersey | — | $199 |
| 2012-04-16 | EIR EIR | Plainsboro, New Jersey | — | $550 |
| 2011-02-18 | EIR EIR | Plainsboro, New Jersey | — | $550 |
| 2011-02-18 | Amended 483 Amended 483 | Plainsboro, New Jersey | 10 | $99 |
Investigators on these documents
Addam S. Reynolds (2)Atul J. Agrawal (2)Claire M. Minden (1)Jessica S. Estriplet (1)Lauren L. Vajo (1)Rebeca Rodriguez (1)Suchan Kim (1)
FEI number 2243092 · most recent document Apr 23, 2025
About Jacobus Pharmaceutical Company, Inc.
How many FDA Form 483s has Jacobus Pharmaceutical Company, Inc. received?
FDA Intel has 3 Form 483s on file for Jacobus Pharmaceutical Company, Inc.; the most recent is dated Apr 23, 2025.
When was Jacobus Pharmaceutical Company, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Jacobus Pharmaceutical Company, Inc. is a Form 483 dated Apr 23, 2025, for the site in PLAINSBORO, New Jersey.
What did FDA cite at Jacobus Pharmaceutical Company, Inc.?
The regulations cited most in the observations on file for Jacobus Pharmaceutical Company, Inc. are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160 (General requirements), 2 times.