Inspections, Compliance, Enforcement, and Criminal Investigations

Fabrica Confecciones Soto, Inc. - Close Out Letter 4/5/17

 

  

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San Juan District
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500 

April 5, 2017

17-SJN-WLCOL-03

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

Mr. Ismael Soto-Cruz
President & Owner
Fábrica Confecciones Soto, Inc
81 Calle Autonomía
Canóvanas, PR 00729-3248

Ref: 16-SJN-WL-03

Dear Mr. Soto-Cruz:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 16-SJN-WL-03 dated 12/18/2015. 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/

Edwin Ramos
Director of Compliance Branch
San Juan District Office 

Page Last Updated: 04/10/2017
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