AGC Biologics Inc.
Form 483 issued March 27, 2024 · Bothell, Washington
- Inspection
- Mar 20 – Mar 27, 2024
- Observations
- 4
- Pages
- 3
- FEI number
- 3000209996
In short: On March 27, 2024, FDA issued a Form 483 with 4 observations to AGC Biologics Inc. in Bothell, Washington (FEI 3000209996) after an inspection that ran Mar 20 – Mar 27, 2024. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Standard Operating Procedures (SOPs) or work instructions are not…
- 02
Sterile tools used during drug substance bulk filling are…
- 03
Your analytical method validation…
- 04
Your equipment maintenance is…
This inspection in context
Questions about this 483
What did FDA find at AGC Biologics Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was AGC Biologics Inc. inspected by FDA?
The inspection ran Mar 20 – Mar 27, 2024, and the Form 483 is dated March 27, 2024.
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.