FDA Form 483 AGC Biologics Inc Bothell, WA - April 2025
Form 483 issued April 14, 2020 · Bothel l, Washington
- Inspection
- Apr 14, 2020
- Observations
- 2
- Pages
- 3
In short: On April 14, 2020, FDA issued a Form 483 with 2 observations to FDA Form 483 AGC Biologics Inc Bothell, WA - April 2025 in Bothel l, Washington after an inspection that ran Apr 14, 2020. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Laboratory controls and materials account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Review of laboratory data for drug substance in-process and release…
- 02
Documentation of critical material…
This inspection in context
Questions about this 483
What did FDA find at FDA Form 483 AGC Biologics Inc Bothell, WA - April 2025?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
When was FDA Form 483 AGC Biologics Inc Bothell, WA - April 2025 inspected by FDA?
The inspection ran Apr 14, 2020, and the Form 483 is dated April 14, 2020.
How do I get the full Form 483 for FDA Form 483 AGC Biologics Inc Bothell, WA - April 2025?
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.