Pharmakon Pharmaceuticals, Inc. - March 16, 2016
Issue Date
Mar 21, 2016
Region
Central
Category
Drug
$117.00
Contact Name
Paul J. Elmer
Contact Title
President and Owner
Address 1
14450 Getz Rd.
City
Noblesville
State
IN
Zip/Postal Code
46060
Country
United States
Inspection Range
Feb 18, 2016 - Mar 16, 2016
Pages
17
First Observation
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
Investigator(s): Emilie Kahn, Lisa T. Michel, Emily J. Orban, and Gary C. Pecic