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CLOSEOUT LETTER

Bioiberica, SAU MARCS-CMS 629115 —

Reference #:
FEI 1000418405
Product:
Drugs
Recipient:
Recipient Name
Mr. Luis Solera Blasco
Recipient Title
Chief Executive Officer
Bioiberica, SAU

Carrer Antic Cami de Tordera 109-119
08389 Palafolls Barcelona
Spain

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

United States

Dear Mr. Luis Solera Blasco:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-22-20 dated June 30, 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/
Rokhsana Safaai-Jazi
Compliance Officer
Division of Drug Quality II

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