FDA Inspection
Howmedica Osteonics Corp.Howmedica Osteonics Corp. – FDA Inspection, Mar 9, 2015
Record Details
This FDA Inspection record concerns Howmedica Osteonics Corp., with an inspection on March 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Howmedica Osteonics Corp.
- Inspection Date
- March 9, 2015
- Product Type
- Devices
View Company Profile
ID · cadeaa06-f6ca-4035-8462-8b3420e8bff3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918064
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Howmedica Osteonics Corp.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 22, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 16, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 15, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 20, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Howmedica Osteonics Corp.
- FDA Inspection 1223869 - 2023-12-01
- FDA Inspection 1147430 - 2021-06-22
- FDA Inspection 830554 - 2013-04-16
- FDA Inspection 644241 - 2010-01-15
- FDA Inspection 598332 - 2009-07-20
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