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  5. Nortec Quimica SA - 639894 - 10/23/2023
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CLOSEOUT LETTER

Nortec Quimica SA MARCS-CMS 639894 —

Product:
Drugs
Recipient:
Recipient Name
Mr. Marcelo C. Mansur
Recipient Title
Chief Executive
Nortec Quimica SA

Rua Dezessete 200 - ABCD Distrito Industrial – Mantiquira
Duque de Caxias-RJ
25250-612
Brazil

marcelo.mansur@nortecquimica.com.br
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Dear Mr. Mansur:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-07 dated December 8, 2022.

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/
Frank Wackes
Compliance Officer
Division of Drug Quality II

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