Emcure Pharmaceuticals USA, Inc. - Jan. 8, 2014
Issue Date
Jan 08, 2014
Region
Central
Category
Drug
$117.00
Contact Name
Fakrul A.A. Sayeed
Contact Title
Chief Executive Officer
Address 1
21 Cotters Ln.
Address 2
Ste B
City
East Brunswick
State
NJ
Zip/Postal Code
08816-2050
Country
United States
Inspection Range
Jan 02, 2014 - Jan 08, 2014
Pages
1
First Observation
An NDA Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical or other change or deterioration in a distributed drug product.
Investigator(s): Barbara J. Wilimczyk-Macri