Nitto Denko Avecia, Inc. - May 10, 2018
Issue Date
May 10, 2018
Region
Northeast
Category
Drug
$117.00
Contact Name
Kelly G. Behrendt
Contact Title
Senior Vice President, Operations
Address 1
125 Fortune Boulevard
City
Milford
State
MA
Zip/Postal Code
01757
Country
United States
Inspection Range
Apr 25, 2018 - May 10, 2018
Pages
1
First Observation
The firm’s sampling procedure for their critical raw materials was inadequate in that the firm routinely composites samples for multiple analyses without scientific data to support this procedure.
Investigator(s): Erik W. Koester