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# Inspection Finds CGMP Deviations at Huron Pharmaceuticals
- URL: https://www.fdaweb.com/inspection-finds-cgmp-deviations-at-huron-pharmaceuticals/
- Published: 2017-05-09T12:00:00.000Z
- Updated: 2026-09-14T22:22:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138644

A 12/13-22/16 FDA inspection at Huron Pharmaceuticals, Farmington Hills, MI, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 4/20 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm556148.htm?ref=fdaweb.com) from the agency’s Detroit District Office. Specific deviations included: 

- failing to transfer all quality or regulatory information received from the API manufacturer to customers;
- failing to establish, document, and implement an effective system for managing quality; and
- failing to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.

“Based on the nature of the deviations we identified at your firm,” the letter says, “we strongly recommend engaging a consultant qualified to evaluate your operations and assist your firm in meeting CGMP requirements.”

Huron was told to correct the deviations promptly and to respond with a list of steps the firm has taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.