South Coast Specialty Compounding, Inc. - March 14, 2016
Issue Date
Mar 14, 2016
Region
Pacific
Category
Drug
$117.00
Contact Name
Nadia Mohamed Ibrahim Elsayed Ibrahim
Contact Title
Director of Operations/Pharmacist in Charge
Address 1
9257 Research Dr.
City
Irvine
State
CA
Zip/Postal Code
92618-4286
Country
United States
Inspection Range
Feb 23, 2016 - Mar 14, 2016
Pages
9
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Investigator(s): Saied A. Asbagh, Darren S. Brown, and Binh T. Nguyen