Laboratorio Magnachem International, S.A. - June 2, 2017
Issue Date
Jun 02, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Jose Diaz
Contact Title
General Manager
Address 1
Avenida Jose Francisco Pena
Address 2
Esquina Calle K
City
Haina, San Cristobal
Zip/Postal Code
11116
Country
Dominican Republic
Inspection Range
May 29, 2017 - Jun 02, 2017
Pages
1
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Jose E. Melendez