FDA Inspection
Zimmer Trabecular Metal Technology, Inc.Zimmer Trabecular Metal Technology, Inc. – FDA Inspection, May 11, 2015
Record Details
This FDA Inspection record concerns Zimmer Trabecular Metal Technology, Inc., with an inspection on May 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 11, 2015
- Product Type
- Devices
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ID · bf611572-1c62-4136-ae90-359c2294f631
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927507
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Zimmer Trabecular Metal Technology, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Zimmer Trabecular Metal Technology, Inc.
- FDA Inspection 1029212 - 2017-09-01
- FDA Inspection 837290 - 2013-06-06
- FDA Inspection 782294 - 2012-05-21
- FDA Inspection 574550 - 2009-04-02
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