Giles Chemical - Nov. 9, 2018
Issue Date
Nov 09, 2018
Region
Southeast
Category
Drug
$117.00
Contact Name
Charles M. Haynes
Contact Title
Director of Operations
Address 1
102 Commerce St.
City
Waynesville
State
NC
Zip/Postal Code
28786-5739
Country
United States
Inspection Range
Nov 06, 2018 - Nov 09, 2018
Pages
6
First Observation
No effective controls are in place to prevent the reprocessing of nonconforming Magnesium Sulfate USP material contaminated with reclaimed (floor and drain) water in the main (bulk) API production plant.
Investigator(s): Christopher S. Keating