Tarmac Products, Inc. dba Axara Pharmaceuticals - June 9, 2011
Issue Date
Jun 09, 2011
Region
Southeast
Category
Drug
$117.00
Address 1
16311 NW 52nd Ave.
City
Hialeah
State
FL
Zip/Postal Code
33014-6209
Country
US
Inspection Range
May 16, 2011 - Jun 09, 2011
Pages
6
First Observation
The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging materials, labeling and drug products.
Investigator(s): Ileana Barreto-Pettit, Gabriel E. Muniz, Teresa I. Navas, and German Rivera