Inspections, Compliance, Enforcement, and Criminal Investigations
Jagg Marketing 2000 Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|466 Fernadez Juncos|
San Juan, Puerto Rico 00901-3223
June 21, 2000
RETURN RECEIPT REQUESTED
Jagg Marketing 2000 Inc.
Lakeside Office Park Door 16
607 North Ave.
Wakefield, Massachusetts 01880
Our Ref: 508-0195323-8
Customs Entry No.: 508-0195323-8
Dear Mr. Corradino:
The Food and Drug Administration (FDA) attempted to examine a shipment of Giulia assorted pasta products offered for import into the United States by your firm on or about April 7, 2000, under entry number 508-0195323-8, and found that the shipment was not held intact pending receipt of "May Proceed" and or availability for FDA examination. Our inspector visited your firm on April 2, 2000, based on information supplied to us by your broker that the product was ready for inspection. Upon arrival at your facility, our inspector was advised that some of the products had already been distributed without an FDA release. Regulations, Title 21, Code of Federal Regulations (CFR), Part 1.90, requires the importer to hold an entry intact pending receipt of a "May Proceed Notice" or "Release Notice" from FDA. Since the product was not made available to us for examination we have requested the U.S. Customs Service (Customs) to order redelivery of the Giulia pasta which have been distributed without a release from FDA (copy of the request is enclosed).
Failure to promptly correct this violation and prevent future violations may result in regulatory action without further notice such as seizure, injunction, or automatic detention of future shipments. It is your responsibility, as the importer, to ensure that imported products meet all requirements of the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder.
We request a response in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the violation, including an explanation of each step being taken to prevent the recurrence of the violation. In addition, you should inform Customs and FDA if and when redelivery is accomplished.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos I. Medina, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, PR 00901.
Mildred R. Barber