MedMira Laboratories, Inc. - Nov. 18, 2021
Issue Date
Nov 18, 2021
Region
HQ
Category
Device
$117.00
Contact Name
Hermes K.W. Chan
Contact Title
Chief Executive Officer
Address 1
155 Chain Lake Dr.
Address 2
Ste. 1, Unit 1
City
Halifax
Zip/Postal Code
B3S 1B3
Country
Canada
Inspection Range
Nov 15, 2021 - Nov 18, 2021
Pages
4
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Ismael Olvera-Iv and Cody D. Rickman