Ei Inspection Finds CGMP Violations

A 10/2-10/6/17 FDA inspection at Ei LLC, Kannapolis, NC, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a just-released 4/16 Warning Letter. Specific violations were: 

·         failing to maintain adequate separate defined areas necessary to prevent contamination or mix-up;

·         failing to establish and follow adequate written procedures for cleaning and maintaining equipment; and

·         failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements. The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion of the actions.