Somersault Orthopedics, Inc
FDA inspection history in Pleasanton, California, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Pleasanton, California.
Cited most
Across all Somersault Orthopedics observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.75(a)Process validation1
- 21 CFR 820.80(c)Receiving, in-process, and finished device acceptance1
The complete Somersault Orthopedics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Pleasanton, California
One Form 483 · 2015 · 5 observations
Latest: Form 483, Feb 26, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-02-26 | 483 Form 483 | Pleasanton, California | 5 | $99 |
Investigators on these documents
FEI number 3010259028 · most recent document Feb 26, 2015
About Somersault Orthopedics, Inc
How many FDA Form 483s has Somersault Orthopedics, Inc received?
FDA Intel has 1 Form 483 on file for Somersault Orthopedics, Inc; the most recent is dated Feb 26, 2015.
When was Somersault Orthopedics, Inc last inspected by FDA?
The most recent FDA inspection document on file for Somersault Orthopedics, Inc is a Form 483 dated Feb 26, 2015, for the site in Pleasanton, California.
What did FDA cite at Somersault Orthopedics, Inc?
The regulations cited most in the observations on file for Somersault Orthopedics, Inc are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.