FDA Inspection
Skeletal Dynamics, Inc.FDA Inspection 1235650 - Skeletal Dynamics, Inc. - April 05, 2024
Record Details
This FDA Inspection record concerns Skeletal Dynamics, Inc., with an inspection on April 5, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 190866c8-26f7-4e67-9036-7053d415f9bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1235650
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Skeletal Dynamics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 29, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Skeletal Dynamics, Inc.
- FDA Inspection 1162542 - 2022-02-18
- FDA Inspection 938043 - 2015-07-29
- FDA Inspection 895894 - 2014-09-15
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.