Neobiosis, LLC - Feb. 21, 2023
Issue Date
Feb 21, 2023
Region
Southeast
Category
Drug
$117.00
Contact Name
Ian A. White
Contact Title
Chief Executive Officer/Chief Scientific Officer
Address 1
305 S.W. 7th Ter.
City
Gainesville
State
FL
Zip/Postal Code
32601-6458
Inspection Range
Jan 23, 2023 - Feb 21, 2023
Pages
5
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic and sterilization process.
Investigator(s): Barbara T. Carmichael and Mizanne E. Lewis