VistaPharm, Inc. - Sept. 2, 2022
Issue Date
Sep 02, 2022
Region
Southeast
Category
Drug
$117.00
Contact Name
Michael A. Brinkley
Contact Title
Chief Quality Officer
Address 1
7265 Ulmerton Rd.
City
Largo
State
FL
Zip/Postal Code
33771-4809
Inspection Range
Aug 25, 2022 - Sep 02, 2022
Pages
4
First Observation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Investigator(s): Steven A. Brettler, Damaris Y. Hernandez, and Nicole E. Knowlton