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# Ei Inspection Finds CGMP Violations
- URL: https://www.fdaweb.com/ei-inspection-finds-cgmp-violations/
- Published: 2018-05-15T12:00:00.000Z
- Updated: 2026-09-15T00:05:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141437

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](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm606805.htm?ref=fdaweb.com). 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.