McNeil Consumer Pharmaceutical Products - March 27, 2015
Issue Date
Apr 09, 2015
Region
Central
Category
Drug
$117.00
Contact Name
Grace De L. Rodriguez
Contact Title
Plant Manager
Address 1
1838 Colonial Village Ln.
City
Lancaster
State
PA
Zip/Postal Code
17601-6700
Country
United States
Inspection Range
Mar 17, 2015 - Mar 27, 2015
Pages
3
First Observation
Control procedures are not established which 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): Thomas E. Friel, Rabin N. Ghoshal, and James M. Mason