FDA Inspection
JMS CO.,Ltd. Chiyoda PlantJMS CO.,Ltd. Chiyoda Plant – FDA Inspection, Mar 25, 2016
Record Details
This FDA Inspection record concerns JMS CO.,Ltd. Chiyoda Plant, with an inspection on March 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- JMS CO.,Ltd. Chiyoda Plant
- Inspection Date
- March 25, 2016
- Product Type
- Devices
View Company Profile
ID · 547c4e34-20ac-4b67-8b4c-c4a5c30d66dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 966461
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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