Noven Pharmaceuticals, Inc. - Jan. 26, 2018
Issue Date
Jan 26, 2018
Region
Southeast
Category
Drug
$117.00
Contact Name
Jeff T. Mihm
Contact Title
Chief Executive Officer
Address 1
11960 S.W. 144th St.
City
Miami
State
FL
Zip/Postal Code
33186
Country
United States
Inspection Range
Jan 18, 2018 - Jan 26, 2018
Pages
4
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Noreen Muniz and Caroline Strasinger