Sun Pharmaceutical Industries Ltd. - Dec. 1, 2016
Issue Date
Dec 01, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Madhukar Ramdin
Contact Title
Senior Vice President of Operations and Halol Site Head
Address 1
Halol-Baroda Highway
City
Halol, Gujarat
Zip/Postal Code
389350
Country
India
Inspection Range
Nov 17, 2016 - Dec 01, 2016
Pages
14
First Observation
Field Alert Reports were not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
Investigator(s): Santos E. Camara and Patric C. Klotzbuecher