Abbey Color, Inc. - 4/3/2016
Issue Date
Apr 03, 2012
Region
Central
Category
Drug
$117.00
Address 1
400 E Tioga St
City
Philadelphia
State
PA
Zip/Postal Code
19134
Country
United States
Inspection Range
Mar 13, 2012 - Mar 23, 2012
Pages
15
First Observation
Testing after cleaning of API process equipment Out-of-specification (OOS) results are not investigated/documented to include analysis of the data, assessment of whether a significant problem exists, allocation of the tasks for corrective actions, and conclusions.
Investigator(s): Matthew R. Noonan