Company
JapanShima Laboratories Co., Ltd., Itabashi, Japan – FDA Inspections
Inspection records and compliance data for Shima Laboratories Co., Ltd. in Itabashi. 2 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected June 09, 2023.
Company Profile
This profile covers Shima Laboratories Co., Ltd. based in Itabashi, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected July 28, 2016. Last inspected June 9, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Retention period1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 9, 2023 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1209311 |
| July 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 988463 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Shima Laboratories Co., Ltd.
FEI Number
3003985394
Address
3 Chome 36-3, Maeno-Cho, Itabashi, Japan
Country
Japan
ID: 1feba4aa-73ed-404c-8959-ed254ec8f8c4