Valeant Pharmacueticals International - Sept. 1, 2016
Issue Date
Sep 01, 2016
Region
Northeast
Category
Device
$117.00
Contact Name
Glenn M. Mattei
Contact Title
Executive Director Compliance Quality Systems and Supplier Management
Address 1
1400 North Goodman St .
City
Rochester
State
NY
Zip/Postal Code
14609
Country
United States
Inspection Range
Aug 23, 2016 - Sep 01, 2016
Pages
4
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
Investigator(s): Nicholas C. Mendiola and Matthew D. Schnittker