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  5. Mylan Laboratories Limited – Unit 7 - 607508 - 02/16/2023
  1. Warning Letters

CLOSEOUT LETTER

Mylan Laboratories Limited – Unit 7 MARCS-CMS 607508 —

Product:
Drugs
Recipient:
Recipient Name
Mr. Michael Goettler
Recipient Title
Chief Executive Officer
Mylan Laboratories Limited – Unit 7

1000 Mylan Boulevard
Canonsburg, PA 15317
United States

Issuing Office:
Office of Manufacturing Quality

United States

Dear Mr. Goettler:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-44 dated August 20, 2020.

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 should deviations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Joseph Lambert, Pharm.D.
Compliance Officer
Division of Drug Quality I

cc:
Mr. Jayachandra Prasad Puttagunta, Vice President of Manufacturing Services
Mylan Laboratories Limited (a Viatris Company) – Unit 7
Plot No. 14, 99&100, Phase-II; IDA, Pashamylaram, Patancheru
Sangareddy District, Telangana – 502307
India

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