FDA 483 - Giles Chemical Corporation a Division of Premier Magnesia, LLC - November 09, 2018

Giles Chemical, an API manufacturer and drug repacker in Waynesville, NC, was cited for multiple significant deficiencies during an FDA inspection. Key issues include inadequate controls for nonconforming material reprocessing, lack of proper procedures for rejected material, and poor label control. Additionally, the firm failed to maintain equipment, ensure proper material staging, adequately qualify automated packaging equipment, and keep comprehensive inventory records.