Green Roads, Inc. dba Clarity Labs - June 17, 2022
Issue Date
Jun 17, 2022
Region
Southeast
Category
Drug
$117.00
Contact Name
Megan A. Alfonso
Contact Title
Vice President of Operations
Address 1
3345 N.W. 74th Ave.
City
Miami
State
FL
Zip/Postal Code
33122-1229
Inspection Range
Jun 13, 2022 - Jun 17, 2022
Pages
5
First Observation
Control procedures are not established which monitor the output and validate the performance of those
manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Joanne E. King