FDA Inspection
LifeSouth Community Blood CentersLifeSouth Community Blood Centers – FDA Inspection, Oct 26, 2023
Record Details
This FDA Inspection record concerns LifeSouth Community Blood Centers, with an inspection on October 26, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 700e7af5-472d-4a84-bac0-c085640eafb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221424
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of LifeSouth Community Blood Centers
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 1, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 30, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 23, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for LifeSouth Community Blood Centers
- FDA Inspection 1107111 - 2019-09-26
- FDA Inspection 1018934 - 2017-07-20
- FDA Inspection 940569 - 2015-09-01
- FDA Inspection 842221 - 2013-07-30
- FDA Inspection 725887 - 2011-05-23
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