Unigen Inc.
Form 483 issued March 9, 2023 · GIFU, Japan
- Inspection
- Mar 2 – Mar 9, 2023
- Investigators
- Anissa M. Cheung· Laurel A. Beer· Prabhu P. Raju
- Observations
- 4
- Pages
- 6
- FEI number
- 3011033616
In short: On March 9, 2023, FDA issued a Form 483 with 4 observations to Unigen Inc. in GIFU, IBI-GUN (FEI 3011033616) after an inspection that ran Mar 2 – Mar 9, 2023. The investigators were Anissa M. Cheung, Laurel A. Beer and Prabhu P. Raju. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
This inspection in context
Anissa M. Cheung
7 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmUnigen Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unigen Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Unigen Inc.?
Anissa M. Cheung, Laurel A. Beer and Prabhu P. Raju are named on this Form 483, for the inspection of Mar 2 – Mar 9, 2023. Each investigator has a profile showing what they cite most.
When was Unigen Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 9, 2023, and the Form 483 is dated March 9, 2023.
How do I get the full Form 483 for Unigen Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.