FDA Inspection
CliniSys, IncCliniSys, Inc – FDA Inspection, Nov 14, 2008
Record Details
This FDA Inspection record concerns CliniSys, Inc, with an inspection on November 14, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- CliniSys, Inc
- Inspection Date
- November 14, 2008
- Product Type
- Biologics
View Company Profile
ID · b53ad122-b8d6-43c4-abe9-c153e8e6e1dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 550852
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.80(d)(3)No release signature
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.100(a)(1)Procedure for analysis of data sources
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CliniSys, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 26, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 15, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CliniSys, Inc
- FDA Inspection 1215144 - 2023-07-27
- FDA Inspection 915421 - 2015-02-26
- FDA Inspection 735003 - 2011-07-15
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