Public Health Service Food and Drug Administration
San Juan District
466 Fernández Juncos Ave.
San Juan, PR 00901-3223
Telephone: (787) 729-8500
September 9, 2015
VIA UNITED PARCEL SERVICE
Richard J. Rosa President/Owner Richies Produce, Inc (FEI: 3009502430) 83 Marfil Street Urb. Rivieras De Cupey San Juan, PR 00926-7430
Dear Mr. Rosa:
On June 3, 2015, your firm offered for Import (lmported) into United States a shipment of Dasheen (Yautia Lila) under Entry 438-0033024-3 line 2/1.
On June 9, 2015, you were notified by means of Notice of FDA Action your product was detained because a previous shipment (April 2015) from same product-grower was found by the Food and Drug Administration (FDA) laboratory analysis to contain Trifloxystrobin and Cyprocozole, two pesticides without tolerance, which causes the Dasheen (Yautia Lila) to be 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 6, 2015, upon evaluated your private laboratory analytical results (PLATS) we refused your shipment of Dasheen (Yautia Lila) product, found to contain Cyprocozole, a pesticide without tolerance by means of a Notice of FDA Action sent to you and to your U.S. Custom Broker designating the entry line Dasheen (Yautia Lila) shipment be detained.
On July 8, 2015, United States Customs Border Protection (CBP) issued a Notice to Redeliver (CBP Form 4647) requesting the redeliver of the Dasheen (Yautia Lila) shipment. Your failure to comply with this Notice is also subject to a CBP penalty action.
On July 16, 2015, despite this refusal, you partially distributed the shipment into U.S. commerce for consumption without an FDA release. This was confirmed by you during our visit to witness product line destruction. Your action constitute a violation of Title 21 of the Code of Federal Regulations (21 CFR), Section 1. 90, which requires the importer hold an imported article and not distribute it pending receipt of the results of examination of the collected sample or a "May Proceed Notice" or a Notice of Release" from FDA.
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 Dasheen (Yautía Lila) causing a full premature distribution into commerce of such Dasheen, 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 these products you distributed are not adulterated and are 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.