FDA 483 - Talbot's Pharmaceuticals Family Products, LLC - May 20, 2026
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Talbot's Pharmaceuticals Family Products, LLC in Monroe, LA, a wholesale distributor, was cited for significant deficiencies in its quality control unit's oversight of contract manufacturers and its internal training program. The firm failed to define responsibilities in contract agreements for critical quality functions like stability studies, change control, and audit rights. Additionally, the firm lacked GMP training records for warehouse personnel, indicating a lack of adequate control over drug product quality and compliance.
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