Coating Place - May 13, 2010
Issue Date
May 13, 2010
Region
Central
Category
Drug
$117.00
Address 1
200 Pool St.
City
Verona
State
WI
Zip/Postal Code
53593
Country
US
Inspection Range
May 11, 2010 - May 13, 2010
Pages
1
First Observation
Batch records, written procedures, and guidances regarding manufacturing of products 617D and 617F are
inadequate in that they lack a description, in sufficient detail, of methods, equipment, and materials employed
in cleaning and sanitation of equipment with product contact surfaces. In addition, these records lack
sufficient description of cleaning verification, sample collection technique and materials.
Investigator(s): Justin A. Boyd and Charles R. Cote