FDA Inspection
Cryopen, LLCCryopen, LLC – FDA Inspection, Apr 30, 2010
Record Details
This FDA Inspection record concerns Cryopen, LLC, with an inspection on April 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cryopen, LLC
- Inspection Date
- April 30, 2010
- Product Type
- Devices
View Company Profile
ID · fa633085-6241-47c9-b3f2-5c8c813b6e28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661679
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 806.20(a)Records not kept
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Other FDA inspections of Cryopen, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cryopen, LLC
- FDA Inspection 1053027 - 2018-03-13
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