Unigen Inc.
Form 483 issued June 15, 2017 · GIFU, Japan
- Inspection
- Jun 12 – Jun 15, 2017
- Investigators
- Deborah Trout· Michele L. Forster· Robin Levis
- Observations
- 7
- Pages
- 1
- FEI number
- 3011033616
In short: On June 15, 2017, FDA issued a Form 483 with 7 observations to Unigen Inc. in GIFU, IBI-GUN (FEI 3011033616) after an inspection that ran Jun 12 – Jun 15, 2017. The investigators were Deborah Trout, Michele L. Forster and Robin Levis. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.67 (3×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation studies for rHA drug substance manufacturing did not include establishment of (B)(A)NNNM limits for…
- 02
Column re-use studies for the (B)/(4) columns for influenza B strains with (B) (4)…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Sanitization efficacy has not been demonstrated for(B) (4) used during the purification…
This inspection in context
Deborah Trout
1 document · 2017
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Japan.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unigen Inc.?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Unigen Inc.?
Deborah Trout, Michele L. Forster and Robin Levis are named on this Form 483, for the inspection of Jun 12 – Jun 15, 2017. Each investigator has a profile showing what they cite most.
When was Unigen Inc. inspected by FDA?
The inspection ran Jun 12 – Jun 15, 2017, and the Form 483 is dated June 15, 2017.
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.