PolyCarbon Industries, Inc. - July 31, 2018
Issue Date
Jul 31, 2018
Region
Northeast
Category
Drug
$117.00
Contact Name
Edward S. Price
Contact Title
President and CEO
Address 1
9 Opportunity Way
City
Newburyport
State
MA
Zip/Postal Code
01950
Country
United States
Inspection Range
Jul 16, 2018 - Jul 31, 2018
Pages
3
First Observation
The firm had failed to adequately evaluate the impact of changes in production steps and equipment on the current validated state of critical intermediates and Active Pharmaceutical Ingredients.
Investigator(s): Robert J. Martin