The U.S. Food and Drug Administration disclosed an inspection that uncovered an unauthorized warehouse tied to Indian generic drugmaker Hetero Labs storing drugs and active pharmaceutical ingredients (APIs) and showing evidence of animal infestation. The FDA report flagged significant cGMP and supply‑chain control deficiencies and potential risks to product sterility and quality. The finding elevates regulatory risk for product approvals and imports tied to the site and underscores intensified FDA scrutiny of overseas API suppliers. API denotes active pharmaceutical ingredients—the chemically active component of medicines—and control of their manufacturing and storage is central to product safety and regulatory compliance.