Imprimis NJOF, LLC
FDA inspection history across 3 sites, 2017 to 2026
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2017: one Form 483; 2019: one close-out letter; 2021: one Form 483; 2024: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–21Two Form 483s and one close-out letter, at Ledgewood, New Jersey and Ledgew.ood, New Jersey.
- 2017The longest 483 on file: 12 observations over 7 pages at Ledgewood, New Jersey.
- 2024–26Two Form 483s, at Ledgewood, New Jersey and Ledgewoo d, New Jersey.
Cited most
Across all Imprimis NJOF observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
The complete Imprimis NJOF file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Ledgewood, New Jersey
Two Form 483s and one close-out letter · 2017 to 2024 · 17 observations
Latest: Form 483, Apr 3, 2024 →Ledgewoo d, New Jersey
One Form 483 · 2026 · 6 observations
Latest: Form 483, Aug 18, 2026 →Ledgew.ood, New Jersey
One Form 483 · 2021 · 3 observations
Latest: Form 483, Jan 29, 2021 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-18 | 483 Form 483 | Ledgewoo d, New Jersey | 6 | $99 |
| 2024-04-03 | 483 Form 483 | Ledgewood, New Jersey | 5 | $99 |
| 2021-01-29 | 483 Form 483 | Ledgew.ood, New Jersey | 3 | $99 |
| 2019-06-07 | Close-out Close-out letter | Ledgewood, New Jersey | — | $99 |
| 2017-07-10 | 483 Form 483 | Ledgewood, New Jersey | 12 | $99 |
Investigators on these documents
Janet A. Rajan (2)Helen Verdel (2)Annet R. Rajan (2)Jose M. Cayuela (1)Louis An (1)Lucila B. Nwatu (1)Rose Jean-Mary (1)Simone E. Pitts (1)Tomika Crafter (1)Carolyn E. Becker (1)Emmanuel J. Ramos (1)
FEI number 3013024146 · most recent document Aug 18, 2026
About Imprimis NJOF, LLC
How many FDA Form 483s has Imprimis NJOF, LLC received?
FDA Intel has 4 Form 483s on file for Imprimis NJOF, LLC; the most recent is dated Aug 18, 2026.
When was Imprimis NJOF, LLC last inspected by FDA?
The most recent FDA inspection document on file for Imprimis NJOF, LLC is a Form 483 dated Aug 18, 2026, for the site in Ledgewoo d, New Jersey.
What did FDA cite at Imprimis NJOF, LLC?
The regulations cited most in the observations on file for Imprimis NJOF, LLC are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.