FDA Inspection
Medivis, Inc.Medivis, Inc. – FDA Inspection, Mar 3, 2026
Record Details
This FDA Inspection record concerns Medivis, Inc., with an inspection on March 3, 2026, issued by the New York District Office, covering medical devices & rad health.
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ID · 001760f4-aa90-415d-b6a1-b69f8316f91e
Inspection Facts
- Inspection number
- 1307926
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.181DMR - not or inadequately maintained
- ISO 13485:2016 Clause 7.3.7Design and development validation not conducted on representative product
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Other FDA inspections of Medivis, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medivis, Inc.
- FDA Inspection 1181772 - 2022-10-17
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