Laboratorios Roldan S.A. - Aug. 19, 2016
Issue Date
Aug 19, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Roberto Rodriguez
Contact Title
Technical Director
Address 1
km 5.5 Carretera Sanchez
City
Santo Domingo
Country
Dominican Republic
Inspection Range
Aug 15, 2016 - Aug 19, 2016
Pages
1
First Observation
Your firm fails to neither have stability data to support the expiration date nor a stability indicating method to determine possible degradation products and/or impurities.
Investigator(s): Heriberto Negron-Rivera