FDA Inspection
Animas CorporationAnimas Corporation – FDA Inspection, Aug 10, 2011
Record Details
This FDA Inspection record concerns Animas Corporation, with an inspection on August 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Animas Corporation
- Inspection Date
- August 10, 2011
- Product Type
- Devices
View Company Profile
ID · 834d70b5-1dc4-40e8-b94d-11ca20c20a15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745496
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Animas Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 8, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Animas Corporation
- FDA Inspection 966243 - 2016-01-27
- FDA Inspection 900703 - 2014-10-08
- FDA Inspection 833476 - 2013-04-12
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