Warning letter

Alchymars ICM SM Private Limited: warning letter of May 21, 2026

FDA warning letter 724429 · Center for Drug Evaluation and Research (CDER)

Key facts

Reference number 724429
Company Alchymars ICM SM Private Limited
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date May 21, 2026
Posted date May 26, 2026
Issuing office Center for Drug Evaluation and Research (CDER)
Product type Drugs
CFR sections cited 211.34
Inspection city Alathur
Inspection start date Nov 28, 2025
Letter on fda.gov fda.gov

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

Browse all FDA warning letters