American Cell Technology, LLC - Oct. 29, 2021
Issue Date
Oct 29, 2021
Region
Southeast
Category
Device
$117.00
Contact Name
Sean T. Berman
Contact Title
Manager & Co-owner
Address 1
13794 N.W. 4th St.
Address 2
Ste. 212
City
Sunrise
State
FL
Zip/Postal Code
33325-6217
Country
United States
Inspection Range
Sep 15, 2021 - Oct 29, 2021
Pages
7
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Investigator(s): Barbara T. Carmichael, Ivan E. Reyes, and Thai D. Truong