Gilead Sciences, Inc. - Dec. 17, 2021
Issue Date
Dec 17, 2021
Region
Pacific
Category
Drug
$117.00
Contact Name
Gerard M. Jensen
Contact Title
Vice President Operations
Address 1
1800 Wheeler St.
City
La Verne
State
CA
Zip/Postal Code
91750-5801
Country
United States
Inspection Range
Dec 06, 2021 - Dec 17, 2021
Pages
7
First Observation
Procedures designed to prevent microbiological contamination of drug products purpoting to be sterile did not include adequate validation of the aseptic process.
Investigator(s): James Arnett, Uttaniti Limchumroon, Jacob G. Lutz, and Dogbeda F. Mackenzie