FDA Inspection
Contego Medical, IncContego Medical, Inc – FDA Inspection, May 22, 2026
Record Details
This FDA Inspection record concerns Contego Medical, Inc, with an inspection on May 22, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · fc66abb1-ae81-4c49-9e4a-fb09b5003eee
Inspection Facts
- Inspection number
- 1311460
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.3Design and development inputs incomplete or inadequate
- ISO 13485:2016 Clause 7.3.6Inadequate design and development verification for interfaced device
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Contego Medical, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2024 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Contego Medical, Inc
- FDA Inspection 1247927 - 2024-08-21
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