Kaneka Corporation
FDA inspection history in Takasago, Japan, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Takasago, Japan.
Cited most
Across all Kaneka observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.160General requirements2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.170Reserve samples1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Kaneka file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Takasago, Japan
One Form 483 · 2023 · 6 observations
Latest: Form 483, Oct 13, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-13 | 483 Form 483 | Takasago, Japan | 6 | $99 |
FEI number 3002807368 · most recent document Oct 13, 2023
About Kaneka Corporation
How many FDA Form 483s has Kaneka Corporation received?
FDA Intel has 1 Form 483 on file for Kaneka Corporation; the most recent is dated Oct 13, 2023.
When was Kaneka Corporation last inspected by FDA?
The most recent FDA inspection document on file for Kaneka Corporation is a Form 483 dated Oct 13, 2023, for the site in Takasago, Japan.
What did FDA cite at Kaneka Corporation?
The regulations cited most in the observations on file for Kaneka Corporation are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.