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CLOSEOUT LETTER

Pfizer Healthcare India Private Limited MARCS-CMS 594972 —

Reference #:
FEI 3008316085
Product:
Drugs
Recipient:
Recipient Name
Mr. Albert Bourla
Recipient Title
Chairman and Chief Executive Officer
Pfizer Healthcare India Private Limited
Pfizer, Inc.

235 East 42nd Street
New York, NY 10017-5703
United States

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Dear Mr. Bourla:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-31 dated March 25, 2020.

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/
Matthew R Dionne
Compliance Officer
Division of Drug Quality II

CC:
Mr. Vikram Shukla, Site Leader
Pfizer Healthcare India Private Limited
Plots 116-117-118-119-111-123 (part)
Jawaharlal Nehru Pharma City, Parawada
Visakhapatnam, Andhra Pradesh, 531 019
India

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