Bershtel Enterprises LLC - Nov. 1, 2018
Issue Date
Nov 01, 2018
Region
Pacific
Category
Drug
$117.00
Contact Name
Vanessa G. Jimenez
Contact Title
Executive Vice President
Address 1
5001 Commerce Dr.
Address 2
Ste. A
City
Baldwin Park
State
CA
Zip/Postal Code
91706-1424
Country
United States
Inspection Range
Oct 15, 2018 - Nov 01, 2018
Pages
4
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