Sumitomo Chemical Company, Limited
FDA inspection history in Ampachicho, Japan, 2009 to 2019
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2016: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter.
- 2016One Form 483, at Ampachicho, Japan.
- 2016The longest 483 on file: 3 observations over 3 pages at Ampachicho, Japan.
- 2019One Form 483, at Ampachicho, Japan.
Cited most
Across all Sumitomo Chemical Company, Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.160General requirements1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Sumitomo Chemical Company, Limited 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
Ampachicho, Japan
Two Form 483s · 2016 to 2019 · 6 observations
Latest: Form 483, Sep 6, 2019 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-06 | 483 Form 483 | Ampachicho, Japan | 3 | $99 |
| 2016-09-23 | 483 Form 483 | Ampachicho, Japan | 3 | $99 |
| 2009-08-24 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Lindsey M. Staley (1)Nona M. Shultis (1)Patty P. Kaewussdangkul (1)
FEI number 3002808125 · most recent document Sep 6, 2019
About Sumitomo Chemical Company, Limited
How many FDA Form 483s has Sumitomo Chemical Company, Limited received?
FDA Intel has 2 Form 483s on file for Sumitomo Chemical Company, Limited; the most recent is dated Sep 6, 2019.
When was Sumitomo Chemical Company, Limited last inspected by FDA?
The most recent FDA inspection document on file for Sumitomo Chemical Company, Limited is a Form 483 dated Sep 6, 2019, for the site in Ampachicho, Japan.
What did FDA cite at Sumitomo Chemical Company, Limited?
The regulations cited most in the observations on file for Sumitomo Chemical Company, Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.
Has Sumitomo Chemical Company, Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sumitomo Chemical Company, Limited; the most recent is dated Aug 24, 2009.