FDA Inspection
Lifesouth Community Blood Centers Inc. - East Alabama RegionLifesouth Community Blood Centers Inc. - East Alabama Region – FDA Inspection, Mar 26, 2025
Record Details
This FDA Inspection record concerns Lifesouth Community Blood Centers Inc. - East Alabama Region, with an inspection on March 26, 2025, issued by the New Orleans District Office, covering biologics.
- Inspection Date
- March 26, 2025
- Product Type
- Biologics
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ID · 105296f3-dcb0-4a45-89f4-2e36f5f0d44a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1264963
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.65(c)Testing of representative samples of reagent lots
- 21 CFR 606.65(e)Following manufacturer's instructions
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 21 CFR 606.100(c)Thorough investigations
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Other FDA inspections of Lifesouth Community Blood Centers Inc. - East Alabama Region
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 11, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 4, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 16, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 9, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Lifesouth Community Blood Centers Inc. - East Alabama Region
- FDA Inspection 1096511 - 2019-07-17
- FDA Inspection 1009379 - 2017-04-11
- FDA Inspection 928979 - 2015-06-04
- FDA Inspection 841087 - 2013-07-16
- FDA Inspection 739663 - 2011-08-09
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