FDA Inspection
Sagami Rubber Industries Co., Ltd.Sagami Rubber Industries Co., Ltd. – FDA Inspection, Jul 24, 2015
Record Details
This FDA Inspection record concerns Sagami Rubber Industries Co., Ltd., with an inspection on July 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 24, 2015
- Product Type
- Devices
View Company Profile
ID · 0f91d5d5-67f4-4c89-8436-95416db830fd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 938490
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sagami Rubber Industries Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sagami Rubber Industries Co., Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.