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Giles Chemical - Nov. 9, 2018

Issue Date

Nov 09, 2018

Region

Southeast

Category

Drug
$117.00

Giles Chemical

Contact Name

Charles M. Haynes

Contact Title

Director of Operations

Form483 Address 1

102 Commerce St.

Form483 Address 2

Form483 City

Waynesville

Form483 State

NC

Form483 Postal

28786-5739

Form483 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