FDA Inspection
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial HospitalDartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital – FDA Inspection, Dec 17, 2015
Record Details
This FDA Inspection record concerns Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital, with an inspection on December 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 17, 2015
- Product Type
- Devices
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ID · e95e41b8-0841-456c-8cfd-b8938c22b3d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953430
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- 21 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2026 | Not classified | New England District Office | |
| June 19, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 25, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 23, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
- FDA Inspection 1320158 - 2026-04-27
- FDA Inspection 1058369 - 2018-06-19
- FDA Inspection 1017963 - 2017-05-26
- FDA Inspection 941242 - 2015-08-25
- FDA Inspection 888655 - 2014-07-23
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