FDA Inspection
DEPUY (IRELAND)DEPUY (IRELAND) – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns DEPUY (IRELAND), with an inspection on December 9, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · db421f5c-1136-43c0-b34c-8b6805301aa2
Inspection Facts
- Inspection number
- 1002434
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of DEPUY (IRELAND)
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 4, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DEPUY (IRELAND)
- FDA Inspection 1245506 - 2024-07-04
- FDA Inspection 912066 - 2015-01-08
- FDA Inspection 772964 - 2012-01-26
- FDA Inspection 712736 - 2011-02-03
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