AGC Biologics Inc.
Form 483 issued April 22, 2016 · Bothell, Washington
- Inspection
- Apr 18 – Apr 22, 2016
- Investigators
- Mikhail Ovanesov· Tieng Liang· Vanessa Y. Gelsey
- Observations
- 4
- Pages
- 2
- FEI number
- 3000209996
In short: On April 22, 2016, FDA issued a Form 483 with 4 observations to AGC Biologics Inc. in Bothell, Washington (FEI 3000209996) after an inspection that ran Apr 18 – Apr 22, 2016. The investigators were Mikhail Ovanesov, Tieng Liang and Vanessa Y. Gelsey. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 3 of 4 observations.
Most cited: 21 CFR 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 is…
- 02
Deviations during production have…
- 03
Preventative maintenance of critical equipment is not…
- 04
Failure to follow standard operating…
This inspection in context
Mikhail Ovanesov
4 documents · 2016–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Austria.
The firmAGC Biologics Inc. history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AGC Biologics Inc.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 AGC Biologics Inc.?
Mikhail Ovanesov, Tieng Liang and Vanessa Y. Gelsey are named on this Form 483, for the inspection of Apr 18 – Apr 22, 2016. Each investigator has a profile showing what they cite most.
When was AGC Biologics Inc. inspected by FDA?
The inspection ran Apr 18 – Apr 22, 2016, and the Form 483 is dated April 22, 2016.
How do I get the full Form 483 for AGC Biologics 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.