Unigen Inc.
FDA inspection history across 2 sites, 2017 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at GIFU, Japan.
- 2017The longest 483 on file: 7 observations over 1 pages at GIFU, Japan.
- 2023One Form 483, at GIFU, Japan.
Cited most
Across all Unigen observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete Unigen 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
GIFU, Japan
Two Form 483s · 2017 to 2023 · 11 observations
Latest: Form 483, Mar 9, 2023 →Tbi District
One Form 483
Latest: Form 483, — →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-09 | 483 Form 483 | GIFU, Japan | 4 | $99 |
| 2017-06-15 | 483 Form 483 | GIFU, Japan | 7 | $99 |
| Undated | 483 Form 483 | Tbi District | — | $99 |
Investigators on these documents
Anissa M. Cheung (1)Deborah Trout (1)Laurel A. Beer (1)Michele L. Forster (1)Prabhu P. Raju (1)Robin Levis (1)
FEI number 3011033616 · most recent document Mar 9, 2023
About Unigen Inc.
How many FDA Form 483s has Unigen Inc. received?
FDA Intel has 3 Form 483s on file for Unigen Inc.; the most recent is dated Mar 9, 2023.
When was Unigen Inc. last inspected by FDA?
The most recent FDA inspection document on file for Unigen Inc. is a Form 483 dated Mar 9, 2023, for the site in GIFU, Japan.
What did FDA cite at Unigen Inc.?
The regulations cited most in the observations on file for Unigen Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.