Pfizer Healthcare India Private Limited

CLOSEOUT LETTER Pfizer Healthcare India Private Limited MARCS-CMS 594972 — February 08, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 02/10/2023 Regulated Product(s) Drugs