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

WARNING LETTER

FLA-01-87

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

storage.

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-

2256.

Sincerely,

Emma R. Singleton

Director, Florida District