Alcami Carolinas Corp. - Oct. 29, 2021
Issue Date
Oct 29, 2021
Region
Southeast
Category
Drug
$117.00
Contact Name
Chad Bovero
Contact Title
Vice President Sterile Operations
Address 1
4221 Faber Place Dr.
City
Charleston
State
SC
Zip/Postal Code
29405-8510
Country
United States
Inspection Range
Oct 18, 2021 - Oct 29, 2021
Pages
4
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
Investigator(s): Santos E. Camara