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# CGMP API Deviations at Hikal Limited
- URL: https://www.fdaweb.com/cgmp-api-deviations-at-hikal-limited/
- Published: 2025-09-09T12:00:00.000Z
- Updated: 2026-09-14T15:21:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159830

A 2/3-2/7 FDA inspection at the Hikal Limited drug manufacturing facility in Jigani, Karnataka, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. An 8/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hikal-limited-709370-08202025?ref=fdaweb.com) says the specific deviations were:

- failure of the firm’s quality unit to ensure that quality-related complaints are investigated and resolved; and
- failure to have a system for evaluating suppliers of critical materials.

FDA recommends that Hikal engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Hikal was told to correct any deviations promptly and to respond with a list of specific actions it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.