FDA Inspection
Summit Orthopedic Technologies, Inc.Summit Orthopedic Technologies, Inc. – FDA Inspection, Feb 15, 2024
Record Details
This FDA Inspection record concerns Summit Orthopedic Technologies, Inc., with an inspection on February 15, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · a9884a94-7697-4f65-9577-0dbf8b87a308
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229989
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Summit Orthopedic Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Summit Orthopedic Technologies, Inc.
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.