Public Health Service Food and Drug Administration
San Juan District
466 Fernández Juncos Ave.
San Juan, PR 00901-3223
Telephone: (787) 729-8500
October 19, 2015
VIA UNITED PARCEL SERVICE
Jorge Diaz Diaz
Caney Distributors Inc. (FEI: 3008976319)
Ponce De Leon Ave 1606, Ste. 1005
San Juan, Puerto Rico 00908
Dear Mr. Diaz:
On April 24, 2015, your firm offered for Import (Imported) into United States a shipment of Long Grain White Milled Rice, a quantity of (b)(4), identified as entry number 9HD-0010461-2, and manufactured by SAMAN, which is listed under Import Alert 99-08, and considered adulterated under Section 402 (a)(2)(B) of the Federal Food Drug and Cosmetic Act or “the Act” [21 U.S.C 342 (a)(2)(B)].
On July 24, 2015, we refused the shipment of this product (long grain white milled rice), and you failed to provide documentation to substantiate compliance with pertienent regulations. A Notice of FDARefusal Action was sent to your U.S. Customs Broker. However, you partially distributed the shipment into U.S. commerce for consumption without an FDA release.
Your action constitutes a violation of Title 21 of the Code of Federal Regulations (21 CFR), Section 1.90, which requires the importer to hold an imported article and not distribute it pending receipt of the results of examination of the collected sample, a “May Proceed Notice,” or a Notice of Release.” Morover, distribution of adulterated white rice with non approved pesticides are in violation of Section 402 (a)(2)(B) of “the Act” [21 U.S.C 342 (a)(2)(B)].
On July 31, 2015, United States Customs Border Protection (CBP) issued a Notice to Redeliver (CBP Form 4647) requesting the redelivery of the white rice shipment, which you failed to adhere. Your failure to comply with this Notice is also subject to a CBP penalty action.
Failure to promptly correct this situation and prevent future premature distribution of imported products may result in future shipments being held in a CBP secured storage facility. Secured storage facilities are under the strict supervision and direction of CBP in a bonded warehouse, and you will be responsible for all costs incurred for holding your product at one of these facilities.
It is your responsibility, as an importer, to ensure that imported products meet all the requirements of the Act and pertinent regulations. You failed to hold intact the shipment of white rice causing a full premature distribution into commerce of such white rice, which has been found adulterated. This is a prohibited act under Section 301(c) of the Act (21 U.S.C. 331(c)). You are responsible for assuring that this product you distributed is not adulterated and is otherwise in compliance with the law. Failure to do so may result in regulatory action, without further notice, such as seizure and/or injunction.
Please provide a response in writing within fifteen (15) working days of receipt of this letter outlining the specific steps you have taken to correct the violation, including an explanation of each step being taken to prevent recurrence of a premature distribution of imported goods subject to FDA examination.
Your written reply should be addressed to the Food and Drug Administration, Attention: Maridalia Torres, District Director, 466 Fernandez Juncos Ave., San Juan, PR 00901. You may also contact Carlos I. Medina, Compliance Officer at (787) 729-8616, if there are questions regarding this Warning Letter.