Fougera Pharmaceuticals Inc.
FDA inspection history in Hicksville, New York, 2022 to 2026
- 3
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s, at Hicksville, New York.
- 2022The longest 483 on file: 2 observations over 3 pages at Hicksville, New York.
- 2026One Form 483, at Hicksville, New York.
Cited most
Across all Fougera Pharmaceuticals observations on file
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.192Production record review1
The complete Fougera Pharmaceuticals 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
Hicksville, New York
Three Form 483s · 2022 to 2026 · 4 observations
Latest: Form 483, Mar 26, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-26 | 483 Form 483 | Hicksville, New York | 1 | $99 |
| 2023-11-17 | 483 Form 483 | Hicksville, New York | 1 | $99 |
| 2022-08-10 | 483 Form 483 | Hicksville, New York | 2 | $99 |
Investigators on these documents
Divek R. Jumani (1)Karishma G. Gopaul (1)Syeda N. Mahazabin (1)
FEI number 2410271 · most recent document Mar 26, 2026
About Fougera Pharmaceuticals Inc.
How many FDA Form 483s has Fougera Pharmaceuticals Inc. received?
FDA Intel has 3 Form 483s on file for Fougera Pharmaceuticals Inc.; the most recent is dated Mar 26, 2026.
When was Fougera Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Fougera Pharmaceuticals Inc. is a Form 483 dated Mar 26, 2026, for the site in Hicksville, New York.
What did FDA cite at Fougera Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Fougera Pharmaceuticals Inc. are 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time.