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CLOSEOUT LETTER

Sucesores De Esmoris & Co., Inc. MARCS-CMS 518991 —


Recipient:
Recipient Name
Mr. James Fox
Recipient Title
President
Sucesores De Esmoris & Co., Inc.
Sucesores De Esmoris & Co., Inc.

5 Comercio St
Mayaguez, PR 00680
United States

Issuing Office:

San Juan District
466 Avenida Fernandez Juncos
San Juan, PR 00901
United States

787-729-8500

 

   

Black HHS-Blue FDA LogoOffice of
Office of Human and Animal Food Operations
East Division IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-850

Office of Regulatory Affairs
Office of Human and Animal Food Operations
East Division IV
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500 

 
 

January 2, 2018

18-HAFE4-WLCOL-02

VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED

Mr. James J. Fox, President
Sucesores de Esmoris & Co., Inc.
5 Comercio St.
Mayagüez, Puerto Rico 00680

Re: Warning Letter, 17-SJN-WL-05 dated 03/07/2017

Dear Mr. Fox:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, 17-SJN-WL-05, dated 03/07/2017. 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 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.

Kind regards,
/S/

Beira Montalvo
Acting, Director of Compliance Branch
OHAFO East Division IV