FDA Inspection
Charles River Laboratories Cell Solutions IncCharles River Laboratories Cell Solutions Inc – FDA Inspection, Apr 19, 2012
Record Details
This FDA Inspection record concerns Charles River Laboratories Cell Solutions Inc, with an inspection on April 19, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 19, 2012
- Product Type
- Biologics
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ID · 42d435a2-7f51-43ee-802e-cc9080891d37
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779402
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
10- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.121(c)(9)Infectious agent statement
- 21 CFR 606.121(c)(4)(i)Expiration date
- 21 CFR 606.121(c)(2)Name, address, unique facility identifier
- 21 CFR 606.121(c)(7)Storage temperature in Celsius
- 21 CFR 606.100(b)(20)Donor deferral
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Charles River Laboratories Cell Solutions Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 31, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 3, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Charles River Laboratories Cell Solutions Inc
- FDA Inspection 1008972 - 2017-04-12
- FDA Inspection 890449 - 2014-07-31
- FDA Inspection 646654 - 2010-02-19
- FDA Inspection 612645 - 2009-09-03
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