PolyCarbon Industries - June 11, 2010
Issue Date
Jun 11, 2010
Region
Northeast
Category
Drug
$117.00
Address 1
9 Opportunity Way
City
Newbury
State
MA
Zip/Postal Code
1950
Country
US
Inspection Range
May 11, 2010 - Jun 11, 2010
Pages
6
First Observation
The Quality Control Unit has failed to investigate an impurity Out-of-Specification for Methscopolamine Nitrate lots 313001N09 and 313001N10, manufactured on 8/12/09 and 4/12/10, respectively. The(b) (4) specification for Methscopolamine Nitrate is no single impurity is greater (b) (4) An unknown impurity was detected on lots 313001N09 and 31300IN10 a(b) (4), respectively.
Investigator(s): Stephan King and Robert J. Martin