AGC Inc.
Form 483 issued October 27, 2023 · Ichihara, Japan
- Inspection
- Oct 23 – Oct 27, 2023
- Observations
- 3
- Pages
- 3
- FEI number
- 3003282601
In short: On October 27, 2023, FDA issued a Form 483 with 3 observations to AGC Inc. in Ichihara, Chiba (FEI 3003282601) after an inspection that ran Oct 23 – Oct 27, 2023. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Unit does not approve scientifically justified and appropriate analytical procedures, sampling, and specifications to…
- 02
Deviations are not adequately investigated or appropriately followed…
- 03
Access to the label storage…
This inspection in context
Questions about this 483
What did FDA find at AGC Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and packaging & labeling. 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 Inc. inspected by FDA?
The inspection ran Oct 23 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
How do I get the full Form 483 for AGC 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.