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483
•Martin Marietta Inc•July 27, 2022

Martin Marietta Inc – FDA 483, Jul 27, 2022

Record Details

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.

Company
Martin Marietta Inc
Inspection date
July 27, 2022
Product type
drugs
Office
Division of Pharmaceutical Quality Operations III
People
  • Rebecca Barth
  • Logan T. Williams (Investigator )
View Company Profile

ID · c0214e2b-be17-4bff-b659-186a25a012fd

Other documents for Martin Marietta Inc
  • 483 - 2026-08-21August 21, 2026

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