Inspections, Compliance, Enforcement, and Criminal Investigations
American Spice Company, Inc. 03-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
555 Winderley Pl., Ste. 200
Maitland, FL 32751
VIA FEDERAL EXPRESS
Ref: Customs Entry No.: D79-0009858-4 Lines 001/-005
Products: Sesame Seeds
October 3, 2001
Mr. Robert Urra President
American Spice Company, Inc.
1100 NW 23rd Street
Miami, Florida 33127
Dear Mr. Urra:
The Food and Drug Administration (FDA), on August 01, 2001, attempted to examine a shipment of assorted spices in accordance with our Notice of FDA Action, dated August 01,2001. The shipment was offered for import (imported) into the United States by your firm on June 22, 2001, under Customs? Entry Number D79-0009858-4. Reportedly, on September 04, 2001, your broker, Mr. Carlos Lastra phoned our Miami office to report that the shipment was unavailable for FDA?s exam. Not holding an entry intact pending a FDA release is a violation of 21 CFR Section 1.90. This Section requires the importer to hold an imported article intact, pending a release notice from FDA.
Failure to promptly correct this situation and prevent future premature distribution of imported product may result in requiring that future shipments be held in secured storage.
Secured storage will be under the supervision and direction of U.S. Customs Service, such as in a bonded warehouse. You will be responsible for all costs incurred in secured storage.
We have requested that U.S. Customs Service order redelivery of the goods which were distributed without a FDA release. Failure to redeliver the entire shipment to Customs custody may result in a penalty action at a later date.
We request 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. In the event that the product is still available for examination, 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 W. Hernandez, Compliance Officer, P.O. BOX 59-2256, Miami, Florida 33159-2256.Sincerely,
Emma R. Singleton
Director, Florida District