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# Alchymars ICM SM Inspection Issues
- URL: https://www.fdaweb.com/alchymars-icm-sm-inspection-issues/
- Published: 2026-05-26T12:00:00.000Z
- Updated: 2026-09-14T13:39:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161195

An 11/28-12/4/2025 FDA inspection at the Alchymars ICM SM Private Limited drug manufacturing facility in Alathur, Tamil Nadu, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 5/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alchymars-icm-sm-private-limited-724429-05212026?ref=fdaweb.com) says the specific violations were:

- failure to ensure that equipment was maintained; and
- failure to properly maintain buildings and equipment used in the manufacturing of APIs.

FDA recommends that Alchymars retain a qualified consultant to perform a comprehensive six-system audit of its entire operation and assist it in meeting CGMP requirements. The agency placed all drugs and drug products offered for import into the U.S. on a 5/19 Import Alert.

Alchymars was told to correct the 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.