Lantheus MI Radipharmaceuticals, Inc. - July 22, 2016
Issue Date
Jul 22, 2015
Region
Southeast
Category
Drug
$117.00
Contact Name
Noel Rodriguez Quiles
Contact Title
Director
Address 1
150 Calle Federico Costa
Address 2
Ste. 1
City
San Juan
State
PR
Zip/Postal Code
00918-1339
Country
United States
Inspection Range
Jul 18, 2016 - Jul 22, 2016
Pages
1
First Observation
You approved a conditional final release of a PET drug product batch due to analytical equipment
malfunction, but you did not document that reasonable efforts had been made to prevent recurrence of the malfunction.
Investigator(s): Laurimer Kuilan-Torres