FDA Inspection
Zimmer, Inc.Zimmer, Inc. – FDA Inspection, May 21, 2012
Record Details
This FDA Inspection record concerns Zimmer, Inc., with an inspection on May 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zimmer, Inc.
- Inspection Date
- May 21, 2012
- Product Type
- Devices
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ID · 6d870558-f3d5-421e-82bc-be08544e9543
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 784525
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Zimmer, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2026 | Not classified | Detroit District Office | |
| July 27, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 28, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zimmer, Inc.
- FDA Inspection 1299270 - 2026-02-09
- FDA Inspection 1177397 - 2022-07-27
- FDA Inspection 1029453 - 2017-10-16
- FDA Inspection 951676 - 2015-11-20
- FDA Inspection 880647 - 2014-05-28
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