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  5. Procter & Gamble Manufactura S. de R.L. de C.V. - 650837 - 03/27/2023
  1. Warning Letters

CLOSEOUT LETTER

Procter & Gamble Manufactura S. de R.L. de C.V. MARCS-CMS 650837 —

Product:
Drugs
Recipient:
Recipient Name
Maria Petry
Procter & Gamble Manufactura S. de R.L. de C.V.

8700 Mason-Montgomery Road
Mason, OH 45040-9462
United States

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Dear Ms. Petrey:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2496. Based on our evaluation, you have discontinued the product listing by adding an end marketing date to the drug listing data thus the warning letter is closed. Future FDA 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. If this product is reintroduced in U.S. commercial distribution, FDA expects that all previous errors are corrected. The Agency expects you and your firm to maintain compliance and to 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/
Tina Smith
Acting Director,
Office of Unapproved Drugs & Labeling Compliance
Center for Drug Evaluation and Research
Office of Compliance
U.S. Food and Drug Administration

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