AGC WAKASA CHEMICALS CO.,LTD.
Form 483 issued November 2, 2023 · OBAMA, Japan
- Inspection
- Oct 30 – Nov 2, 2023
- Observations
- 4
- Pages
- 3
- FEI number
- 3005175594
In short: On November 2, 2023, FDA issued a Form 483 with 4 observations to AGC WAKASA CHEMICALS CO.,LTD. in OBAMA, FUKUI (FEI 3005175594) after an inspection that ran Oct 30 – Nov 2, 2023. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations are not adequately investigated or appropriately followed…
- 02
Personnel are not adequately trained to manufacture the…
- 03
Documents are not controlled with a control number in…
- 04
Your Quality Unit does not approve scientifically justified and appropriate analytical procedures to make sure that…
This inspection in context
Questions about this 483
What did FDA find at AGC WAKASA CHEMICALS CO.,LTD.?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
When was AGC WAKASA CHEMICALS CO.,LTD. inspected by FDA?
The inspection ran Oct 30 – Nov 2, 2023, and the Form 483 is dated November 2, 2023.
How do I get the full Form 483 for AGC WAKASA CHEMICALS CO.,LTD.?
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.