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Tapi Puerto Rico, Inc. - Nov. 17, 2014
Issue Date
Nov 17, 2014
Region
Southeast
Category
Drug
$117.00
Contact Name
Braulio Santiago
Contact Title
General Manager
Address 1
Hwy. No.3 Km 76.3
Address 2
Humacao Industrial Park
City
Humacao
State
PR
Zip/Postal Code
00791
Country
Puerto Rico
Inspection Range
Nov 05, 2014 - Nov 17, 2014
Pages
2
First Observation
The batch production record corresponding to 5-Flourouracil drug substance is deficient in that it does not include data confirming the adequacy of the in-process sampling during the sieving step.
Investigator(s): Jose R. Lopez and Jose E. Melendez