FDA Inspection
CS Medical LLCCS Medical LLC – FDA Inspection, Sep 16, 2009
Record Details
This FDA Inspection record concerns CS Medical LLC, with an inspection on September 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CS Medical LLC
- Inspection Date
- September 16, 2009
- Product Type
- Devices
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ID · 847ed9ba-ca09-45fd-8639-e6796e054594
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613293
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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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 |
| May 8, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for CS Medical LLC
- FDA Inspection 1004480 - 2017-03-01
- FDA Inspection 878536 - 2014-05-08
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