CLOSEOUT LETTER
Natco Pharma Limited MARCS-CMS 672564 —
- Product:
- Drugs
- Recipient:
-
Recipient NameMr. Sandeep Kumar
-
Recipient TitleVice President - Quality
- Natco Pharma Limited
Pharma Division, Kothur Village
Rangareddy 509228
Telangana
India
- Issuing Office:
- Center for Drug Evaluation and Research (CDER)
United States
United States
Dear Mr. Kumar:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-24-32 dated August 8, 2024.
Based on our evaluation, it appears that you have addressed the violations 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 should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Rafael Arroyo
Compliance Officer
Division of Drug Quality I