Einstein Works, LLC - March 23, 2022
Issue Date
Mar 23, 2022
Region
Southwest
Category
Device
$117.00
Contact Name
Stephen Ford
Contact Title
Quality Manager
Address 1
5312 Elm St.
City
Houston
State
TX
Zip/Postal Code
77081
Country
United States
Inspection Range
Mar 21, 2022 - Mar 23, 2022
Pages
3
First Observation
The firm lacks established procedures for Medical Device Reporting (MDR) and has not created an FDA Electronic Submissions Gateway (ESG) account for electronic Medical Device Reporting (eMDR) to ensure that FDA can process, review, and archive MDRs submitted by your firm.