AGC Biologics Inc.
Form 483 issued November 2, 2020 · Bothell, Washington
- Investigators
- Christopher R. Czajka· On Ths Kathryn King
- Observations
- 6
- Pages
- 4
- FEI number
- 3000209996
In short: On November 2, 2020, FDA issued a Form 483 with 6 observations to AGC Biologics Inc. in Bothell, Washington (FEI 3000209996). The investigators were Christopher R. Czajka and On Ths Kathryn King. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Harvest filtration unit operation not running…
- 02
Incomplete root cause…
- 03
Your firm lacks adequate assurance that the unit operations for UM manufacturing process are…
- 04
Quality assurance (QA) oversight…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
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 6 observations on this Form 483, mostly about production and quality system. 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.?
Christopher R. Czajka and On Ths Kathryn King are named on this Form 483. Each investigator has a profile showing what they cite most.
When was AGC Biologics Inc. inspected by FDA?
This Form 483 is dated November 2, 2020.
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.