FDA Inspection
Piedmont Augusta Transfusion ServicePiedmont Augusta Transfusion Service – FDA Inspection, Dec 20, 2013
Record Details
This FDA Inspection record concerns Piedmont Augusta Transfusion Service, with an inspection on December 20, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 20, 2013
- Product Type
- Biologics
View Company Profile
ID · 3e3fae40-f58a-41ee-bdde-6a0508a8cef3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859922
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.140(c)Adequate identification and handling of test samples
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)(9)Written methods for investigating adverse reactions
- 21 CFR 606.170(a)Adverse Reaction- Reports of 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 Piedmont Augusta Transfusion Service
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 1, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 24, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 14, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 17, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Piedmont Augusta Transfusion Service
- FDA Inspection 1249192 - 2024-08-07
- FDA Inspection 1062693 - 2018-08-01
- FDA Inspection 974974 - 2016-06-24
- FDA Inspection 798719 - 2012-09-14
- FDA Inspection 697890 - 2010-11-17
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.