Caraco Pharmaceutical Laboratories, Ltd. - May 30, 2013
Issue Date
May 30, 2013
Region
Central
Category
Drug
$117.00
Contact Name
Rajesh (NMI) Kapoor, Ph.D
Contact Title
VP, Quality
Address 1
1150 Elijah Dr.
City
Detroit
State
MI
Zip/Postal Code
48202-3344
Country
United States
Inspection Range
May 21, 2013 - May 30, 2013
Pages
1
First Observation
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
Investigator(s): Andrew J. Idzior, Sarah M. Napier, Emily J. Orban, and Aurora-Miha Trifanov