Somnowell, Inc
Form 483 issued March 10, 2016 · Bellevue, Tennessee
- Inspection
- Feb 11 – Mar 10, 2016
- Investigator
- Mary A. Millner
- Observations
- 9
- Pages
- 5
- FEI number
- 3011669995
In short: On March 10, 2016, FDA issued a Form 483 with 9 observations to Somnowell, Inc in Bellevue, Tennessee (FEI 3011669995) after an inspection that ran Feb 11 – Mar 10, 2016. The investigator was Mary A. Millner. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
Written MDR procedures have not been developed…
- 03
The design history file…
- 04
Procedures for design change…
This inspection in context
Mary A. Millner
9 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Tennessee.
The firmSomnowell, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Somnowell, Inc?
FDA listed 9 observations on this Form 483, mostly about cAPA, design controls and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Somnowell, Inc?
Mary A. Millner is named on this Form 483, for the inspection of Feb 11 – Mar 10, 2016. Each investigator has a profile showing what they cite most.
When was Somnowell, Inc inspected by FDA?
The inspection ran Feb 11 – Mar 10, 2016, and the Form 483 is dated March 10, 2016.
How do I get the full Form 483 for Somnowell, 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.