FDA Inspection
Cypress Medical Products LLCCypress Medical Products LLC – FDA Inspection, Feb 8, 2012
Record Details
This FDA Inspection record concerns Cypress Medical Products LLC, with an inspection on February 8, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cypress Medical Products LLC
- Inspection Date
- February 8, 2012
- Product Type
- Devices
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ID · a23aaf26-20da-4512-9cc9-903ff02c5a5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767155
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Cypress Medical Products LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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