Patheon Puerto Rico, Inc. - August 11, 2014
Issue Date
Aug 11, 2014
Region
Southeast
Category
Drug
$117.00
Contact Name
Francis Vazquez
Contact Title
Executive Director and General Manager
Address 1
State Rd. 670, Km. 2.7
Address 2
Barrio Campo Alegre
City
Manati
State
PR
Zip/Postal Code
00674
Country
United States
Inspection Range
Aug 04, 2014 - Aug 11, 2014
Pages
4
First Observation
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
Investigator(s): Jose A. Cruz-Gonzalez and Miguel A. Martinez