Somnowell, Inc
FDA inspection history in Bellevue, Tennessee, 2016
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2016: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One warning letter and one Form 483, at Bellevue, Tennessee.
Cited most
Across all Somnowell observations on file
- 21 CFR 820.30(i)Design controls2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
The complete Somnowell file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bellevue, Tennessee
One warning letter and one Form 483 · 2016 · 9 observations
Latest: Warning letter, May 12, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-05-12 | Warning letter Warning letter | Bellevue, Tennessee | — | $99 |
| 2016-03-10 | 483 Form 483 | Bellevue, Tennessee | 9 | $99 |
Investigators on these documents
FEI number 3011669995 · most recent document May 12, 2016
About Somnowell, Inc
How many FDA Form 483s has Somnowell, Inc received?
FDA Intel has 1 Form 483 on file for Somnowell, Inc; the most recent is dated Mar 10, 2016.
When was Somnowell, Inc last inspected by FDA?
The most recent FDA inspection document on file for Somnowell, Inc is a Form 483 dated Mar 10, 2016, for the site in Bellevue, Tennessee.
What did FDA cite at Somnowell, Inc?
The regulations cited most in the observations on file for Somnowell, Inc are 21 CFR 820.30(i) (Design controls), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Somnowell, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Somnowell, Inc; the most recent is dated May 12, 2016.