Cosmax Usa, Corporation
FDA inspection history across 2 sites, 2014 to 2023
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Close-out
- Form 483
2014: one Form 483; 2017: one Form 483; 2023: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Carteret, New Jersey.
- 2017One Form 483, at Carteret, New Jersey.
- 2017The longest 483 on file: 4 observations over 4 pages at Carteret, New Jersey.
- 2023One close-out letter, at Ridgefield Park, New Jersey.
Cited most
Across all Cosmax Usa observations on file
- 21 CFR 211.166Stability testing2
- 21 CFR 211.192Production record review2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.25Personnel qualifications1
The complete Cosmax Usa file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Carteret, New Jersey
Two Form 483s · 2014 to 2017 · 8 observations
Latest: Form 483, Sep 20, 2017 →Ridgefield Park, New Jersey
One close-out letter · 2023
Latest: Close-out, Mar 1, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-01 | Close-out Close-out letter | Ridgefield Park, New Jersey | — | $99 |
| 2017-09-20 | 483 Form 483 | Carteret, New Jersey | 4 | $99 |
| 2014-12-22 | 483 Form 483 | Carteret, New Jersey | 4 | $99 |
Investigators on these documents
FEI number 3002679704 · most recent document Mar 1, 2023
About Cosmax Usa, Corporation
How many FDA Form 483s has Cosmax Usa, Corporation received?
FDA Intel has 2 Form 483s on file for Cosmax Usa, Corporation; the most recent is dated Sep 20, 2017.
When was Cosmax Usa, Corporation last inspected by FDA?
The most recent FDA inspection document on file for Cosmax Usa, Corporation is a Form 483 dated Sep 20, 2017, for the site in Carteret, New Jersey.
What did FDA cite at Cosmax Usa, Corporation?
The regulations cited most in the observations on file for Cosmax Usa, Corporation are 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.