Cubist Pharmaceuticals, Inc. - July 10, 2014
Issue Date
Jul 10, 2014
Region
Northeast
Category
Drug
$117.00
Contact Name
Michael W. Bonney
Contact Title
Chief Executive Officer
Address 1
66 Hayden Ave.
City
Lexington
State
MA
Zip/Postal Code
02421
Country
United States
Inspection Range
May 29, 2014 - Jul 10, 2014
Pages
13
First Observation
The Quality Unit failed to investigate, adequately investigate and/or implement permanent corrective actions for events that could impact the safety and/or the quality of the drug product.
Investigator(s): Stacey S. Degarmo, Ramon E. Martinez, and Mary McGarry