U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Aurobindo Pharma Limited - 577033 - 02/09/2023
  1. Warning Letters

CLOSEOUT LETTER

Aurobindo Pharma Limited MARCS-CMS 577033 —

Reference #:
FEI 3004611182
Product:
Drugs
Recipient:
Recipient Name
Mr. K. Nithyananda Reddy
Recipient Title
Managing Director
Aurobindo Pharma Limited

Sy. No. 61-66, IDA, Pydibhimavaram, Ranasthalam (Mandal)
Srikakulam District 532409
Andhra Pradesh
India

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Dear Mr. Reddy:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-27 dated June 20, 2019.

Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.

The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action deviations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Tamara Rosbury, Ph.D.
Compliance Officer
Division of Drug Quality II

Back to Top