Watson Laboratories - Florida - September 4, 2009
Issue Date
Sep 04, 2009
Region
Southeast
Category
Drug
$117.00
Address 1
4955 Orange Dr.
City
Davie
State
FL
Zip/Postal Code
33314
Country
US
Inspection Range
Aug 24, 2009 - Sep 04, 2009
Pages
7
First Observation
You failed to report information in ANDA 78-436 Amphetamines Extended-Release capsules pertinent to an evaluation of this application.
Investigator(s): Craig A. Garmendia and Robert D. Tollefsen