FDA Inspection
JMS CO., LTD., Miyoshi PlantJMS CO., LTD., Miyoshi Plant – FDA Inspection, Oct 25, 2024
Record Details
This FDA Inspection record concerns JMS CO., LTD., Miyoshi Plant, with an inspection on October 25, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- JMS CO., LTD., Miyoshi Plant
- Inspection Date
- October 25, 2024
- Product Type
- Medical Devices & Rad Health
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ID · dcf92a76-b7ce-4df2-8252-8b233e7e784f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253981
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of JMS CO., LTD., Miyoshi Plant
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for JMS CO., LTD., Miyoshi Plant
- FDA Inspection 947326 - 2015-09-11
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