FDA Inspection
CS Medical LLCCS Medical LLC – FDA Inspection, May 8, 2014
Record Details
This FDA Inspection record concerns CS Medical LLC, with an inspection on May 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CS Medical LLC
- Inspection Date
- May 8, 2014
- Product Type
- Devices
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ID · a03e8566-ad61-4fb6-bfff-c29595a5310e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 878536
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of CS Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 16, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CS Medical LLC
- FDA Inspection 1004480 - 2017-03-01
- FDA Inspection 613293 - 2009-09-16
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