Unigen Inc.
Form 483 · Tbi District
- Observations
- 4
- Pages
- 6
- FEI number
- 3011033616
In short: FDA issued a Form 483 with 4 observations to Unigen Inc. in Tbi District (FEI 3011033616). Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
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 writing…
- 02
There is a fai lure to thoroughly review any unexplained discrepancy, the fa ilure of a…
- 03
Written records of investigations into unexplained discrepanciesifihe failure of a batch or any of its components…
- 04
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
This inspection in context
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 211.192 (production record review). The opening words of each observation are shown on this page.
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.