Froggy's Fog, LLC - Sept. 15, 2021
Issue Date
Sep 15, 2021
Region
Southeast
Category
Device
$117.00
Contact Name
Adam Pogue
Contact Title
Owner and CEO
Address 1
1536 N. Main St.
City
Mount Pleasant
State
TN
Zip/Postal Code
38474-4020
Country
United States
Inspection Range
Sep 15, 2021 - Sep 15, 2021
Pages
2
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Susan O. Oladeji