FDA 483 - Giles Chemical - July 27, 2022

Giles Chemical, a division of Premier Magnesium LLC, a bulk Magnesium Sulfate manufacturer in Greendale, IN, was cited for significant quality system deficiencies. Observations include a lack of established critical process parameters, inadequate raw material release procedures, absence of microbiological testing, and poor facility sanitation. The firm also failed to properly investigate complaints, implement preventative maintenance, and ensure correct product labeling before shipment.