PETNET Solutions South Florida - June 24, 2021
Issue Date
Jun 28, 2021
Region
Southeast
Category
Drug
$117.00
Contact Name
Radu V. Ciocan
Contact Title
Vice President
Address 1
5553 Anglers Ave.
Address 2
Ste. 112
City
Fort Lauderdale
State
FL
Zip/Postal Code
33312-6655
Country
United States
Inspection Range
Jun 15, 2021 - Jun 24, 2021
Pages
7
First Observation
You are not able to demonstrate that your process for producing the PET drug is capable of producing a drug product that meets its predetermined acceptance criteria.
Investigator(s): Jennifer L. Huntington