Sekisui Medical Co., Ltd. 4-115, Matsuo
FDA inspection history in Iwate, Japan, 2016
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter and one Form 483, at Iwate, Japan.
Cited most
Across all Sekisui Medical Co., Ltd. 4-115, Matsuo observations on file
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Sekisui Medical Co., Ltd. 4-115, Matsuo file.
All 2 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
Iwate, Japan
One Form 483 · 2016 · 1 observation
Latest: Form 483, Jun 17, 2016 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-11-08 | Warning letter Warning letter | — | — | $99 |
| 2016-06-17 | 483 Form 483 | Iwate, Japan | 1 | $99 |
Investigators on these documents
FEI number 3002806840 · most recent document Nov 8, 2016
About Sekisui Medical Co., Ltd. 4-115, Matsuo
How many FDA Form 483s has Sekisui Medical Co., Ltd. 4-115, Matsuo received?
FDA Intel has 1 Form 483 on file for Sekisui Medical Co., Ltd. 4-115, Matsuo; the most recent is dated Jun 17, 2016.
When was Sekisui Medical Co., Ltd. 4-115, Matsuo last inspected by FDA?
The most recent FDA inspection document on file for Sekisui Medical Co., Ltd. 4-115, Matsuo is a Form 483 dated Jun 17, 2016, for the site in Iwate, Japan.
What did FDA cite at Sekisui Medical Co., Ltd. 4-115, Matsuo?
The regulations cited most in the observations on file for Sekisui Medical Co., Ltd. 4-115, Matsuo are 21 CFR 211.194 (Laboratory records), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.
Has Sekisui Medical Co., Ltd. 4-115, Matsuo received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sekisui Medical Co., Ltd. 4-115, Matsuo; the most recent is dated Nov 8, 2016.