Toaster Labs, Inc. - Dec. 21, 2018
Issue Date
Dec 21, 2018
Region
Pacific
Category
Device
$117.00
Contact Name
Amy C. Buckalter
Contact Title
CEO
Address 1
768 Garfield St.
City
Seattle
State
WA
Zip/Postal Code
98109-3005
Country
United States
Inspection Range
Dec 17, 2018 - Dec 21, 2018
Pages
5
First Observation
The written MDR procedure does not include an internal system which provides for the timely and
effective evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Christopher S. Genther