NIPPON FINE CHEMICAL CO.,LTD
FDA inspection history in TAKASAGO, Japan, 2016 to 2019
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: one warning letter; 2017: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19One warning letter, one close-out letter and one Form 483, at TAKASAGO, Japan.
Cited most
Across all NIPPON FINE CHEMICAL CO.,LTD observations on file
- 21 CFR 211.180General requirements1
- 21 CFR 211.192Production record review1
The complete NIPPON FINE CHEMICAL CO.,LTD file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
TAKASAGO, Japan
One Form 483 and one warning letter · 2016 to 2019 · 3 observations
Latest: Form 483, Jun 11, 2019 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-11 | 483 Form 483 | TAKASAGO, Japan | 3 | $99 |
| 2017-03-23 | Close-out Close-out letter | — | — | $99 |
| 2016-09-26 | Warning letter Warning letter | TAKASAGO, Japan | — | $99 |
FEI number 3001722961 · most recent document Jun 11, 2019
About NIPPON FINE CHEMICAL CO.,LTD
How many FDA Form 483s has NIPPON FINE CHEMICAL CO.,LTD received?
FDA Intel has 1 Form 483 on file for NIPPON FINE CHEMICAL CO.,LTD; the most recent is dated Jun 11, 2019.
When was NIPPON FINE CHEMICAL CO.,LTD last inspected by FDA?
The most recent FDA inspection document on file for NIPPON FINE CHEMICAL CO.,LTD is a Form 483 dated Jun 11, 2019, for the site in TAKASAGO, Japan.
What did FDA cite at NIPPON FINE CHEMICAL CO.,LTD?
The regulations cited most in the observations on file for NIPPON FINE CHEMICAL CO.,LTD are 21 CFR 211.180 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has NIPPON FINE CHEMICAL CO.,LTD received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for NIPPON FINE CHEMICAL CO.,LTD; the most recent is dated Sep 26, 2016.