FDA 483 - Preferred Pharmaceuticals, Inc. - May 27, 2025
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An FDA inspection of Preferred Pharmaceuticals, Inc. in Anaheim, CA, a repacker/relabeler, revealed two significant observations. The firm failed to maintain appropriate computer system controls, including shared logins and unlogged workstations, leading to potential data integrity issues for production records. Additionally, critical equipment used for repackaging drug products lacked proper installation, operation, or process validation, impacting product quality and safety.
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