Coupler Enterprises CGMP Inspection Violations

A 2/26-3/10 FDA inspection at Coupler Enterprises, Warrington, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/15 Warning Letter says specific violations were: 

•          failing to inspect the packaging and labeling facilities immediately before use to assure that all drug products have been removed from the previous operations;
•          failing to establish and follow adequate written procedures for cleaning and maintenance of equipment; and
•          failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

Coupler was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing the actions.