FDA Inspection
TELEMEDTELEMED – FDA Inspection, Mar 16, 2023
Record Details
This FDA Inspection record concerns TELEMED, with an inspection on March 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d4f3c781-e37f-4278-a2ee-63f20e500d5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199983
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TELEMED
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| December 13, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| August 3, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for TELEMED
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