Somersault Orthopedics, Inc
Form 483 issued February 26, 2015 · Pleasanton, California
- Inspection
- Feb 11 – Feb 26, 2015
- Investigator
- Seema S. Singh
- Observations
- 5
- Pages
- 4
- FEI number
- 3010259028
In short: On February 26, 2015, FDA issued a Form 483 with 5 observations to Somersault Orthopedics, Inc in Pleasanton, California (FEI 3010259028) after an inspection that ran Feb 11 – Feb 26, 2015. The investigator was Seema S. Singh. Most observations concern cAPA and production & process controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for the acceptance of in-process product…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Written MDR procedures have…
This inspection in context
Seema S. Singh
6 documents · 2015–2020
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmSomersault Orthopedics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Somersault Orthopedics, Inc?
FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Somersault Orthopedics, Inc?
Seema S. Singh is named on this Form 483, for the inspection of Feb 11 – Feb 26, 2015. Each investigator has a profile showing what they cite most.
When was Somersault Orthopedics, Inc inspected by FDA?
The inspection ran Feb 11 – Feb 26, 2015, and the Form 483 is dated February 26, 2015.
How do I get the full Form 483 for Somersault Orthopedics, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.