Contract Coating, Inc. - 4/9/2012
Issue Date
Apr 09, 2012
Region
Central
Category
Drug
$117.00
Address 1
161 Beech Street
City
Hackensack
State
NJ
Zip/Postal Code
07601
Country
United States
Inspection Range
Apr 02, 2012 - Apr 09, 2012
Pages
2
First Observation
Batch records used to record the manufacturing of drug products at the firm do not establish mixing and coating times to be followed; when and how samples are taken during the coating process; and specifications for thickness of coating and spray gun distance from coating bed.
Investigator(s): Liatte Krueger