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  1. Warning Letters


Flanes Lymar

Flanes Lymar

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

 Food and Drug Administration
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Telephone: 787-729-8500
FAX: 787-729-8826

AUG 12 2015


Return Receipt Requested

Mr. Luis Santos Morales
Flanes Lymar
68 Capitan Correa Street
Ponce, Puerto Rico 00730

Dear Mr. Santos:

We have completed an evaluation of your firm's corrective actions in response to our Warning Letter 13-SJN-WL-02 dated November 19, 2012. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.

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 Agency 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.

Should you have questions and/or comments regarding this matter, please feel free to contact me at the district office address provided in the letterhead. You may also contact Ms. Marilyn Santiago, Compliance Officer at telephone number 787-729-8707 or at marilyn.santiago@fda.hhs.gov.

Kind regards,


Edwin Ramos
Director of Compliance
San Juan District Office

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