FDA Inspection
Imedia NY IncImedia NY Inc – FDA Inspection, Oct 23, 2024
Record Details
This FDA Inspection record concerns Imedia NY Inc, with an inspection on October 23, 2024, issued by the New York District Office, covering medical devices & rad health.
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ID · 1a517de7-1095-4c82-96dc-2ac8d92dca38
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1230619
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of Imedia NY Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Imedia NY Inc
- FDA Inspection 1122424 - 2020-01-16
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