Pharmakon Compounding Pharmacy, Inc. - May 4, 2016
Issue Date
May 06, 2016
Region
Central
Category
Drug
$117.00
Contact Name
Jason E. Prokopik
Contact Title
Chief Operating Officer
Address 1
14460 Getz Rd.
Address 2
Ste. 300
City
Noblesville
State
IN
Zip/Postal Code
46060
Country
United States
Inspection Range
Apr 18, 2016 - May 06, 2016
Pages
10
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): Constantin Y. Philopoulos and Charles L. Zhou