Inspections, Compliance, Enforcement, and Criminal Investigations
Dade South Fruits & Vegetables 18-Sep-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
555 Winderley Place Suite 200
Maitland, FL 32751
VIA FEDERAL EXPRESS
Ref: Customs Entry No: J75-1032486-0 Line 001/001
Product: Fresh Genips
September 18, 2001
Mr. Wilfiedo Sanchez, President
Dade South Fruits and Vegetables, Inc.
8700 NW 10lst Street
Medley, Florida 33178
Dear Mr. Sanchez:
The Food and Drug Administration (FDA), on August 20, 2001, attempted to examine a
shipment of fresh genips in accordance with our Notice of FDA Action, dated August 19,
2001. The shipment was offered for import (imported) into the United States by your firm
on August 18, 2001, under Customs? Entry Number J75-1 032486-0. During our visual
examination we noted that ninety cases (2,250 pounds) out of the original one hundred
and fifteen cases were already distributed without a FDA release. Reportedly, these
ninety cases of produce were brought back to your facility on, or about, August 27,2001.
On August 28, 2001, we returned to your facility to verify the return of the ninety cases
of genips previously distributed, and to verify that the entry was still held in tact. Our
examination noted that not all the original product was available. There were still 1,000
pounds of product missing, and the Manager at your firm stated in an affidavit that some
of the product had been sold to several customers in Maryland and New York. Not
holding an entry in tact pending a FDA release is a violation of 21 CFR Section 1.90.
This Section requires the importer to hold an imported article in tact, 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
We will be requesting that U.S. Customs Service order redelivery of the 1,000 pounds
which were distributed without a FDA release. Failure to redeliver the missing portion 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-
Emma R. Singleton
Director, Florida District