19 Aug 2025

🚫FDA Debars Doyal Kalita for 10 Years from Drug Importation

Doyal Kalita: Final Debarment Order

Summary

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Doyal Kalita for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kalita was convicted of two felony counts under Federal law. The factual basis supporting Mr. Kalita's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kalita was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of June 26, 2025 (30 days after receipt of the notice), Mr. Kalita had not responded. Mr. Kalita's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$$ - High

The FDA's debarment of Doyal Kalita, due to felony convictions related to drug importation, significantly affects compliance and regulatory requirements for businesses in the pharmaceutical and importation sectors. Companies involved in drug imports must ensure that individuals with prior convictions do not handle their operations, affecting staffing and compliance protocols.

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