Destileria Serralles, Inc. - Aug. 9, 2016
Issue Date
Aug 09, 2016
Region
Southeast
Category
Drug
$117.00
Contact Name
Silvia Santiago
Contact Title
Senior Vice President Manufacturing
Address 1
PR Road 5506 KM1.8
City
Mercedita
State
PR
Zip/Postal Code
00715
Country
United States
Inspection Range
Jul 28, 2016 - Aug 09, 2016
Pages
9
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 material, labeling and drug products.
Investigator(s): Marian E. Ramirez and Jose Velez