AGC Biologics Inc.
Form 483 issued March 19, 2021 · Bothell, Washington
- Inspection
- Mar 19, 2021
- Investigators
- Christopher R. Czajka· Gas Aer· Natanie Phillips-Sylvain
- Observations
- 16
- Pages
- 14
- FEI number
- 3000209996
In short: On March 19, 2021, FDA issued a Form 483 with 16 observations to AGC Biologics Inc. in Bothell, Washington (FEI 3000209996) after an inspection that ran Mar 19, 2021. The investigators were Christopher R. Czajka, Gas Aer, Natanie Phillips-Sylvain, Nataniel Phillips-Syivain, Nathaniel B. Phillips-Sylvain, Reife Hie, Restise Ape Vayne Seifert, Revers Ac Riley Myers and Riley Myers. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 10 of 16 observations.
Most cited: 21 CFR 211.192 (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
Manufacturing steps not included in the master batch records (MBR) are conducted without approval…
- 02
A manufacturing system has not been adequately…
- 03
The Quality Unit failed…
- 04
Master production and control records do not contain all information necessary to ensure that manufacturing processes…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AGC Biologics Inc.?
FDA listed 16 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected AGC Biologics Inc.?
Christopher R. Czajka, Gas Aer, Natanie Phillips-Sylvain, Nataniel Phillips-Syivain, Nathaniel B. Phillips-Sylvain, Reife Hie, Restise Ape Vayne Seifert, Revers Ac Riley Myers and Riley Myers are named on this Form 483, for the inspection of Mar 19, 2021. Each investigator has a profile showing what they cite most.
When was AGC Biologics Inc. inspected by FDA?
The inspection ran Mar 19, 2021, and the Form 483 is dated March 19, 2021.
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.