FDA Inspection
TELEMEDTELEMED – FDA Inspection, Dec 13, 2018
Record Details
This FDA Inspection record concerns TELEMED, with an inspection on December 13, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e8b32b2a-98a0-4597-801a-6bed0596e92b
Inspection Facts
- Inspection number
- 1075788
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of TELEMED
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| March 16, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 3, 2017 | Not classified | Office of Inspections and Investigations |
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