FDA Inspection
LifeSouth Community Blood Centers - Shoals RegionLifeSouth Community Blood Centers - Shoals Region – FDA Inspection, Jun 6, 2017
Record Details
This FDA Inspection record concerns LifeSouth Community Blood Centers - Shoals Region, with an inspection on June 6, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 6, 2017
- Product Type
- Biologics
View Company Profile
ID · 508e4b79-0d18-4617-aba5-285790ab53e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012966
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 630.10(g)(1)Proof Of Identity
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.65(e)Following manufacturer's instructions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LifeSouth Community Blood Centers - Shoals Region
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2014 | 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 19, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 28, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for LifeSouth Community Blood Centers - Shoals Region
- FDA Inspection 907577 - 2014-12-17
- FDA Inspection 841647 - 2013-07-16
- FDA Inspection 742298 - 2011-08-19
- FDA Inspection 674007 - 2010-07-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.