FDA Inspection
Shoulder OptionsShoulder Options – FDA Inspection, Oct 26, 2015
Record Details
This FDA Inspection record concerns Shoulder Options, with an inspection on October 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Shoulder Options
- Inspection Date
- October 26, 2015
- Product Type
- Devices
View Company Profile
ID · a617e022-1124-4b96-a718-90972de1b054
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 950617
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
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.