FDA Inspection
C.R. Bard Inc.C.R. Bard Inc. – FDA Inspection, Jun 5, 2026
Record Details
This FDA Inspection record concerns C.R. Bard Inc., with an inspection on June 5, 2026, issued by the New York District Office, covering medical devices & rad health.
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ID · 1404f136-b049-4b8e-99c7-4fa4e5985103
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1320526
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of C.R. Bard Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 28, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for C.R. Bard Inc.
- FDA Inspection 1055471 - 2018-05-21
- FDA Inspection 991406 - 2016-10-28
- FDA Inspection 979209 - 2016-04-29
- FDA Inspection 963298 - 2016-03-02
- FDA Inspection 956346 - 2016-01-08
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