FDA Inspection
Ventana Medical Systems, Inc.Ventana Medical Systems, Inc. – FDA Inspection, Feb 10, 2026
Record Details
This FDA Inspection record concerns Ventana Medical Systems, Inc., with an inspection on February 10, 2026, issued by the Denver District Office, covering medical devices & rad health.
- Inspection Date
- February 10, 2026
- Product Type
- Medical Devices & Rad Health
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ID · cde65d82-4dc6-4666-98c8-091fc5c1de76
Inspection Facts
- Inspection number
- 1302296
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.5.6Planned results not consistently met during validation of processes
- ISO 13485:2016 Clause 8.2.2Correction or corrective action resulting from complaint handling not documented
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Other FDA inspections of Ventana Medical Systems, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 15, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 29, 2021 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 26, 2020 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 14, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Ventana Medical Systems, Inc.
- FDA Inspection 1180876 - 2022-09-23
- FDA Inspection 1181638 - 2022-09-15
- FDA Inspection 1151204 - 2021-07-29
- FDA Inspection 1121325 - 2020-02-26
- FDA Inspection 1102775 - 2019-08-14
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