Spray-Tek, Inc. - April 22, 2016
Issue Date
Apr 22, 2016
Region
Central
Category
Drug
$117.00
Contact Name
David J. Broadwell
Contact Title
Quality/Regulatory Manager
Address 1
3010 Avenue B
City
Bethlehem
State
PA
Zip/Postal Code
18017
Country
United States
Inspection Range
Apr 20, 2016 - Apr 22, 2016
Pages
1
First Observation
The current process for evaluating new and existing products, being processed in your facility on non-dedicated equipment, does not include a documented review to assess the need for cleaning validation or verification based on the solubility and toxicity of the products.
Investigator(s): James M. Mason