Fill It Pack It, Inc. - Nov. 5, 2018
Issue Date
Nov 05, 2018
Region
Pacific
Category
Drug
$117.00
Contact Name
Robert L. Miller
Contact Title
Vice President
Address 1
2555 E. Del Arno Blvd.
City
Compton
State
CA
Zip/Postal Code
90221-6001
Country
United States
Inspection Range
Oct 26, 2018 - Nov 05, 2018
Pages
3
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Investigator(s): Bryan A. Galvez and Alan L. Truong