FDA Inspection
General Hospital Corporation (The)General Hospital Corporation (The) – FDA Inspection, Apr 28, 2014
Record Details
This FDA Inspection record concerns General Hospital Corporation (The), with an inspection on April 28, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 28, 2014
- Product Type
- Biologics
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ID · 44f4a242-0dbf-409c-8ada-e29ccebbbe2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 876646
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 640.3(f)Donations in less than eight weeks
- 21 CFR 610.53(b)Dating periods for licensed biological products
- 21 CFR 610.47(a)(1)Review Records ID Previous Donations [Collecting Estab]
- 21 CFR 610.46(a)(1)Review Records to ID Previous Donations [Collecting Estab]
- 21 CFR 606.171Biological product deviation report
- 21 CFR 640.4(f)Arm preparation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of General Hospital Corporation (The)
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 23, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 17, 2019 | Not classified | New England District Office | Drug Quality Assurance |
| January 31, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 24, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for General Hospital Corporation (The)
- FDA Inspection 1241625 - 2024-05-23
- FDA Inspection 1110333 - 2019-10-23
- FDA Inspection 1094535 - 2019-06-17
- FDA Inspection 1042063 - 2018-01-31
- FDA Inspection 999897 - 2017-01-24
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