MiMedx Group, Inc. - March 2, 2023
Issue Date
Mar 02, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Ricci S. Whitlow
Contact Title
Chief Operating Officer
Address 1
300 Townpark Dr. N.W. 260
City
Kennesaw
State
GA
Zip/Postal Code
30144-5807
Inspection Range
Feb 22, 2023 - Mar 02, 2023
Pages
5
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): Christopher J. Adams, Marla A. Cassidy, and Cody D. Rickman