Curexa
FDA inspection history across 2 sites, 2020 to 2023
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2020: two Form 483s; 2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–23Three Form 483s and one warning letter, at Egg Harbor Township, New Jersey and Egg Harbor, New Jersey.
- 2022The longest 483 on file: 3 observations over 6 pages at Egg Harbor Township, New Jersey.
Cited most
Across all Curexa observations on file
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.58Maintenance1
The complete Curexa file.
All 4 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
Egg Harbor Township, New Jersey
Two Form 483s and one warning letter · 2020 to 2023 · 6 observations
Latest: Warning letter, Sep 13, 2023 →Egg Harbor, New Jersey
One Form 483 · 2020 · 1 observation
Latest: Form 483, Sep 27, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-13 | Warning letter Warning letter | Egg Harbor Township, New Jersey | — | $99 |
| 2022-09-09 | 483 Form 483 | Egg Harbor Township, New Jersey | 3 | $99 |
| 2020-10-09 | 483 Form 483 | Egg Harbor Township, New Jersey | 3 | $99 |
| 2020-09-27 | 483 Form 483 | Egg Harbor, New Jersey | 1 | $99 |
Investigators on these documents
Frederick Razzaghi (1)Jessica S. Estriplet (1)Nancy M. Espinal (1)Sena G. Dissmeyer (1)William J. Muszynski (1)
FEI number 3011761882 · most recent document Sep 13, 2023
About Curexa
How many FDA Form 483s has Curexa received?
FDA Intel has 3 Form 483s on file for Curexa; the most recent is dated Sep 9, 2022.
When was Curexa last inspected by FDA?
The most recent FDA inspection document on file for Curexa is a Form 483 dated Sep 9, 2022, for the site in Egg Harbor Township, New Jersey.
What did FDA cite at Curexa?
The regulations cited most in the observations on file for Curexa are FDCA 501(a)(2)(A) (Insanitary conditions), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.
Has Curexa received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Curexa; the most recent is dated Sep 13, 2023.