FDA Inspection
The General Hospital CorporationThe General Hospital Corporation – FDA Inspection, Dec 18, 2015
Record Details
This FDA Inspection record concerns The General Hospital Corporation, with an inspection on December 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 18, 2015
- Product Type
- Devices
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ID · cfb98e52-6cb4-4339-92f6-5685374ac034
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953244
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 803.30(a)(1)Report of Death Within 10 Days
- 21 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days
- 21 CFR 803.17Lack of Written MDR Procedures
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