FDA Inspection
DePuy Orthopaedics, Inc.DePuy Orthopaedics, Inc. – FDA Inspection, Nov 26, 2012
Record Details
This FDA Inspection record concerns DePuy Orthopaedics, Inc., with an inspection on November 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DePuy Orthopaedics, Inc.
- Inspection Date
- November 26, 2012
- Product Type
- Devices
View Company Profile
ID · 87161292-687d-4078-a1e2-a18b9a492c67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809912
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DePuy Orthopaedics, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 12, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 8, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2019 | Not classified | Detroit District Office | |
| September 1, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DePuy Orthopaedics, Inc.
- FDA Inspection 1230524 - 2024-03-28
- FDA Inspection 1170215 - 2022-05-12
- FDA Inspection 1112319 - 2019-11-08
- FDA Inspection 1108253 - 2019-04-25
- FDA Inspection 1024164 - 2017-09-01
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.