FDA Inspection
Hemosphere, Inc. (A CryoLife, Inc. Company)Hemosphere, Inc. (A CryoLife, Inc. Company) – FDA Inspection, Feb 14, 2014
Record Details
This FDA Inspection record concerns Hemosphere, Inc. (A CryoLife, Inc. Company), with an inspection on February 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 14, 2014
- Product Type
- Devices
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ID · 4ea503cd-fdf7-4d67-b4ad-abb13bdbba59
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869118
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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