FDA Inspection
Walter L. Shepeard Community Blood Center, Inc.Walter L. Shepeard Community Blood Center, Inc. – FDA Inspection, May 15, 2009
Record Details
This FDA Inspection record concerns Walter L. Shepeard Community Blood Center, Inc., with an inspection on May 15, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 15, 2009
- Product Type
- Biologics
View Company Profile
ID · 29a41716-78b9-4f3a-b363-7fb17420cb92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 588275
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Walter L. Shepeard Community Blood Center, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | NAI | Blood and Blood Products | |
| September 1, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 3, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 21, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 16, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Walter L. Shepeard Community Blood Center, Inc.
- FDA Inspection 1269616 - 2025-06-05
- FDA Inspection 1179488 - 2022-09-01
- FDA Inspection 1097500 - 2019-07-03
- FDA Inspection 1020494 - 2017-07-21
- FDA Inspection 909673 - 2015-01-16
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