Topiderm, Inc. - Oct. 9, 2018
Issue Date
Oct 09, 2018
Region
Northeast
Category
Drug
$117.00
Contact Name
Eric K. Stern
Contact Title
President
Address 1
5200 New Horizons Blvd.
City
Amityville
State
NY
Zip/Postal Code
11701-1189
Country
United States
Inspection Range
Oct 01, 2018 - Oct 09, 2018
Pages
3
First Observation
Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience, which is required to be reported to the Food and Drug Administration.
Investigator(s): Jose O. Hernandez