FDA Inspection
LifeSouth Community Blood Centers Inc - Huntsville Hospital Donor CenterLifeSouth Community Blood Centers Inc - Huntsville Hospital Donor Center – FDA Inspection, Apr 16, 2010
Record Details
This FDA Inspection record concerns LifeSouth Community Blood Centers Inc - Huntsville Hospital Donor Center, with an inspection on April 16, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 16, 2010
- Product Type
- Biologics
View Company Profile
ID · 58cef333-2724-4a15-b496-0145a29f83bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658434
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LifeSouth Community Blood Centers Inc - Huntsville Hospital Donor Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 7, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 6, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 4, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for LifeSouth Community Blood Centers Inc - Huntsville Hospital Donor Center
- FDA Inspection 1048434 - 2018-04-04
- FDA Inspection 954535 - 2016-01-07
- FDA Inspection 869571 - 2014-03-06
- FDA Inspection 753726 - 2011-11-04
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