FDA Inspection
C.R. Bard IncC.R. Bard Inc – FDA Inspection, Apr 19, 2016
Record Details
This FDA Inspection record concerns C.R. Bard Inc, with an inspection on April 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- C.R. Bard Inc
- Inspection Date
- April 19, 2016
- Product Type
- Devices
View Company Profile
ID · 62c4d67b-748b-4d6b-af31-dbe511db6f3a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967364
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of C.R. Bard Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 28, 2020 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 8, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 5, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for C.R. Bard Inc
- FDA Inspection 1237149 - 2024-11-12
- FDA Inspection 1117926 - 2020-01-28
- FDA Inspection 1058864 - 2018-06-08
- FDA Inspection 866588 - 2014-02-05
- FDA Inspection 792420 - 2012-07-25
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