FDA Inspection
Gottfried Medical, Inc.Gottfried Medical, Inc. – FDA Inspection, Jul 31, 2025
Record Details
This FDA Inspection record concerns Gottfried Medical, Inc., with an inspection on July 31, 2025, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · 1e5315e5-2355-48ac-b480-2e9858bcfed3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1229541
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
3- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 801.20(a)Label to bear a unique device identifier
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Other FDA inspections of Gottfried Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 24, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gottfried Medical, Inc.
- FDA Inspection 981652 - 2016-07-15
- FDA Inspection 918081 - 2015-03-24
- FDA Inspection 675506 - 2010-07-27
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