Mallinckrodt, Inc. - Jan. 8, 2015
Issue Date
Jan 08, 2015
Region
Southwest
Category
Drug
$117.00
Contact Name
Dale B. Eyman
Contact Title
Site Director
Address 1
2703 Wagner Pl.
City
Maryland Heights
State
MO
Zip/Postal Code
63043-3412
Country
United States
Inspection Range
Dec 17, 2014 - Jan 08, 2015
Pages
2
First Observation
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved and written procedures before a batch is released or distributed.
Investigator(s): Shafiq S. Ahadi and Edward E. Lockwood