FDA Inspection
Medstar Cardiovascular Research NetworkMedstar Cardiovascular Research Network – FDA Inspection, May 22, 2024
Record Details
This FDA Inspection record concerns Medstar Cardiovascular Research Network, with an inspection on May 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 372b00e4-d50e-438c-9dc7-0b0deb0217af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239286
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(2)Sponsor device shipment records inadequate
- 21 CFR 812.40Sponsors' general responsibilities
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