FDA Inspection
Morris Innovative, Inc.Morris Innovative, Inc. – FDA Inspection, Jan 26, 2016
Record Details
This FDA Inspection record concerns Morris Innovative, Inc., with an inspection on January 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Morris Innovative, Inc.
- Inspection Date
- January 26, 2016
- Product Type
- Devices
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ID · 4ddbeb6e-9a00-4ff4-85fe-fee73ed51c1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958725
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of Morris Innovative, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 22, 2010 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Morris Innovative, Inc.
- FDA Inspection 819336 - 2013-02-01
- FDA Inspection 700412 - 2010-10-22
- FDA Inspection 697076 - 2010-10-22
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