FDA Inspection
ReNovo, Inc.ReNovo, Inc. – FDA Inspection, May 18, 2023
Record Details
This FDA Inspection record concerns ReNovo, Inc., with an inspection on May 18, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7d60c4da-f658-4f68-9e34-b37a3b3aacce
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1205740
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of ReNovo, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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