Praxair, Inc., Puerto Rico B.V. - Jan. 28, 2014
Issue Date
Jan 28, 2014
Region
Southeast
Category
Drug
$117.00
Contact Name
Raymond Nelson
Contact Title
Operations and Distribution Manager
Address 1
Humacao Industrial Park
Address 2
Road #3, Km. 77.6
City
Humacao
Zip/Postal Code
00791
Country
Puerto Rico
Inspection Range
Jan 23, 2014 - Jan 28, 2014
Pages
1
First Observation
Control procedures are not established which monitor the output an 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): Dayna I. Martinez