FDA Inspection
Geisinger Medical Center Blood BankGeisinger Medical Center Blood Bank – FDA Inspection, Jan 24, 2019
Record Details
This FDA Inspection record concerns Geisinger Medical Center Blood Bank, with an inspection on January 24, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Cara M. Minelli (Issuing Officer)
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ID · bff246f3-015a-4173-be20-e0dad7891dce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077348
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.60(b)Equipment calibration frequency
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Other FDA inspections of Geisinger Medical Center Blood Bank
10| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 3, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 16, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 11, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 6, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Geisinger Medical Center Blood Bank
- FDA Inspection 1119128 - 2020-01-14
- FDA Inspection 1049028 - 2018-04-03
- FDA Inspection 993518 - 2016-11-16
- FDA Inspection 971865 - 2016-05-11
- FDA Inspection 902585 - 2014-11-06
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