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# CGMP Deviations Seen in Glicerinas Inspection
- URL: https://www.fdaweb.com/cgmp-deviations-seen-in-glicerinas-inspection/
- Published: 2024-01-23T12:00:00.000Z
- Updated: 2026-09-14T14:20:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156192

A 5/8-5/12/2023 FDA inspection at the Glicerinas Industriales drug manufacturing facility in Zapopan, Mexico, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 1/16 Warning Letter says the specific deviations were:

- failing to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their certificate of authority; and
- failing to document, explain, and investigate any deviation from established procedures.

FDA recommends that Glicerinas retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed the firm on an import alert on 1/16\. It noted that Glicerinas had been placed on an earlier import alert and had been issued a Warning Letter on 6/13/2022 for refusing an inspection.

The company was told to correct the deviations promptly and to respond with a list of specific steps it has taken to correct the deviations and prevent their recurrence, with a schedule for completing the work.