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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Pro*Act Specialties 17-May-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

555 Winderley PI., Ste. 200
Maitland, FL 32751


 


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-05-38

May 17, 2005

Dean Simon, President
Pro*Act Specialties
1205 Wholesale Street
Los Angeles, California 90021

Ref Customs Entry No:[redacted]
Product: Fresh Snow Peas

Dear Mr. Simon:

On January 26, 2005, your firm offered for import (imported) into the United States a shipment of fresh snow peas 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, [redacted],requesting to hold the shipment pursuant to FDA Import Alert 99-14. At the same time, the FDA issued a written Notice of FDA Action, dated January 25, 2005, designating the entire shipment be detained and held for examination.

On February 4, 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 snow peas 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 the U.S. Customs and Border Protection (CBP) to require redelivery of the missing portion of the snow peas 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 audit sample from the portion of snow peas available at the time. The snow peas sample was analyzed to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act). The snow peas sample tested positive for pesticide chemicals, methamidophos and chlorothalonil. Because there is no-established tolerance set by the Environmental Protection Agency for either of these pesticides for snow peas (Sections 180.275 and 180.315 of Title 40 of the Code of Federal Regulations), they are unsafe within the meaning of Section 408(a) of the Act [21 U.S.C.346a(a)]. The snow peas are deemed adulterated within the meaning of Section 402(a)(2)(B) of the Act [21 U.S.C. 342(a)(2)(B)]. Under that section, a food is deemed to be adulterated if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe. A Notice of FDA Action was issued to inform you of the violation.

I would like to remind you that Section 801(a) of the Act [21 U.S.C.381(a)(1) 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 food products must be completed under the supervision of an FDA representative. As stated above, the snow peas under entry [redacted] are subject to a Notice of Refusal of Admission, dated March 7, 2005, pursuant to Section 801(a)(3) of the Act [21 U.S.C.381(a)(3)] in that it was found to contain pesticide chemicals that are unsafe, which is in violation of Section 402(a)(2)(B) of the Act [21 U.S.C.342(a)(2)(B)]. 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 Act and regulations promulgated thereunder. You failed to hold intact the shipment of snow peas causing a partial premature distribution into commerce of such peas, which have been found adulterated. This is a prohibited act under Section 301 of the Act [21 U.S.C. 331]. You are responsible for ensuring 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 import alert detention and/or 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.


Sincerely,

/S/

Emma R. Singleton

Director, Florida District