AGC Biologics Inc.
Form 483 issued July 23, 2021 · Bothell, Washington
- Observations
- 3
- Pages
- 3
- FEI number
- 3000209996
In short: On July 23, 2021, FDA issued a Form 483 with 3 observations to AGC Biologics Inc. in Bothell, Washington (FEI 3000209996). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at AGC Biologics Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was AGC Biologics Inc. inspected by FDA?
This Form 483 is dated July 23, 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.