Inspections, Compliance, Enforcement, and Criminal Investigations
Cafeteria Adelita 30-Mar-05
Department of Health and Human Services
Public Health Service
555 Winderley PI ., Ste. 200
RETURN RECEIPT REQUESTED
Ref: Customs Entry No.: D79-0012897-7
Product: Fresh Cheese
March 30, 2005
Adela Marina Alcantara, President
3820 NW 36th St.
Miami, FL 33142
Dear Ms. Alcantara:
On December 22, 2004, your firm offered for import (imported) into the United States a shipment of cheese under the above referenced entry number. On the same day, the Food and Drug Administration (FDA) sent an electronic message through the Automated Broker Interface (ABI) system to your broker requesting submission of entry documents for review . Subsequently, on December 27, 2004, the FDA issued a written Notice of FDA Action, designating the entire shipment be held for examination.
On January 6, 2005, representatives of the FDA attempted to examine the product covered by the Notice of FDA Action and found that the product was partially unavailable for examination, because a portion of the cheese shipment had already been distributed for consumption without an FDA release. This is in violation of Section 1 .90 of Title 21 of the Code of Federal Regulations, which requires the importer to hold an entry intact pending receipt of a "May Proceed Notice" or "Notice of Release" from FDA. We requested U.S . Customs and Border Protection (CBP) to require redelivery of the missing portion of the cheese product that you failed to hold for FDA examination.
Failure to redeliver the missing portion to CBP custody may result in a penalty action at a later date. Furthermore, the FDA representatives collected an import sample from the portion of cheese available at the time. The cheese sample was analyzed to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act). FDA analysis of the cheese found it to contain high levels of E. Coli and Alkaline Phosphatase, which causes the cheese to be adulterated under of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. Under that section, a food is deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health . A Notice of FDA Action (Detention), dated 02/01/2005, was issued to inform you of the violation.
I would like to remind you that section 801(a) [21 U.S.C. 381(a)] of the Act directs issuing a Notice of Refusal when it appears from examination of samples, or otherwise,
that an imported shipment is in violation. This Section also provides for the destruction of any such shipment refused admission, unless it is exported within 90 days of the date of the notice, or within such additional time as may be permitted pursuant to regulations. Destructions of such violative food products must be completed under the supervision of an FDA representative. As stated above, the cheese under- entry D79-0012897-7 is subject to refusal of admission pursuant to Section 801(a)(3) of the Act [21 U.S.C. 381(a)(3)] in that it was found to contain high levels of E. Coli and Alkaline Phosphatase, in violation of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] . You may refer to the Notice for specific information in this matter.
It is your responsibility, as an importer, to ensure that imported products meet all the requirements of the Federal Food, Drug and Cosmetic Act and regulations promulgated thereunder. You failed to hold intact the shipment of cheese causing a partial premature distribution into commerce of such cheese, 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 the products you distribute 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 goods subject to examination. In the event that the partially distributed product becomes available, you should inform CBP and FDA if and when redelivery is accomplished.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos W. Hernandez, Compliance Officer, 6601 NW 25th St., Suite 241, Miami, Florida 33122.
Jimmy Wathall for Emma R. Singleton
Director, Florida District