Kaneka Corporation
Form 483 issued October 13, 2023 · Takasago, Japan
- Observations
- 6
- Pages
- 6
- FEI number
- 3002807368
In short: On October 13, 2023, FDA issued a Form 483 with 6 observations to Kaneka Corporation in Takasago, Hyogo (FEI 3002807368). Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (3×) · 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
Controls to prevent contamination are deficient…
- 02
Out of Specification (OOS) investigation and…
- 03
Analytical Methods are not…
- 04
Procedures describing CAPA (Corrective and Preventive Action) related to drug substance are…
This inspection in context
Questions about this 483
What did FDA find at Kaneka Corporation?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Kaneka Corporation inspected by FDA?
This Form 483 is dated October 13, 2023.
How do I get the full Form 483 for Kaneka Corporation?
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.