CLOSEOUT LETTER
Blends Maker Manufacturing Inc
- Recipient:
- Blends Maker Manufacturing Inc
United States
- Issuing Office:
United States
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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 |
June 30, 2017
17- OHAFOEDIV4-WLCOL-05
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
Mr. Antonio José Lazaro-Santos
President
Cocktail House Manufacturing Company Inc
(Formerly Blends Maker Manufacturing Inc)
261 Calle Azucena
Urb. La Serranía
Caguas, PR 00725
Ref: 12-SJN-WL-08
Dear Mr. Lazaro-Santos:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 12-SJN-WL-08 dated 08/28/2012. 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
OHAFO East Division IV