FDA Inspection
EMED Technologies CorporationEMED Technologies Corporation – FDA Inspection, Feb 7, 2017
Record Details
This FDA Inspection record concerns EMED Technologies Corporation, with an inspection on February 7, 2017, issued by the San Francisco District Office, covering medical devices & rad health.
- Inspection Date
- February 7, 2017
- Product Type
- Medical Devices & Rad Health
- Person
- Seema S. Singh (Issuing Officer)
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ID · d4b75bae-d03b-4396-84d4-9f0749b0e8a5
Inspection Facts
- Inspection number
- 1000056
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
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Other FDA inspections of EMED Technologies Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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