Chartwell Pharmaceuticals, LLC - May 1, 2015
Issue Date
May 01, 2015
Region
Northeast
Category
Drug
$117.00
Contact Name
Kimberly A. Ezdebski
Contact Title
Vice President Quality and Regulatory Compliance
Address 1
77 Brenner Dr.
City
Congers
State
NY
Zip/Postal Code
10920
Country
United States
Inspection Range
Apr 27, 2015 - May 01, 2015
Pages
1
First Observation
Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences.
Investigator(s): Sony Mathews