FDA Inspection
Summit Orthopedic Technologies, Inc.Summit Orthopedic Technologies, Inc. – FDA Inspection, Oct 3, 2018
Record Details
This FDA Inspection record concerns Summit Orthopedic Technologies, Inc., with an inspection on October 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · f09a2c13-74ec-4913-a54c-eacca305edb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067738
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Summit Orthopedic Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2024 | 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.