McNeil Healthcare, LLC - January 8, 2010
Issue Date
Jan 08, 2010
Region
Southeast
Category
Drug
$117.00
Address 1
Road #183, Km 19.8
Address 2
Bo. Montones
City
Las Piedras
State
PR
Zip/Postal Code
771
Country
US
Inspection Range
Oct 22, 2009 - Jan 08, 2010
Pages
8
First Observation
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
Investigator(s): Jose R. Lopez and Raquel Gonzalez Rivera