Departmentof Health and Human Services PublicHealth Service New Orleans District
Southeast Region
6600 Plaza Drive Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
Facsimile: 504-253-4520
March 18, 2003
WARNING LETTER NO. 2003-NOL-12
FEDERAL EXPRESS
Overnight Delivery
Mr. Ghulam H. Ansary, President and Owner
A Spicy World Company
2423 Bainbridge, Suite 200
Kenner, Louisiana 70065
Dear Mr. Ansary:
The U.S. Food and Drug Administration (FDA) inspected your spice processing and associated food storage warehouse facility, located at 2423 Bainbridge, Suite 200, Kenner, Louisiana, during January 21, 22, and 28, 2003. The inspection was conducted to determine compliance with FDA?s Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR), Part 110. During the inspection, our investigators documented numerous insanitary conditions, which caused the ingredients and finished food products manufactured, packed, and/or held at your facility to become adulterated. The adulterated ingredients and finished food products are in violation of Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, in that they consist in whole or in part of filthy substances, including rodent excreta pellets, and had been held under insanitary conditions whereby they may have become contaminated with filth.
Evidence of rodent activity was observed in, on, and near foods stored in your spice processing and food storage facility. This evidence included live and dead rodents, rodent excreta pellets, rodent urine stains, and gnawed food packaging. Evidence of rodent gnawing and general rodent activity was observed on several different food product packaging material including, but not limited to, poppy seeds, black pepper, and meat tenderizer. Our FDA laboratory confirmed the findings of rodent excreta pellets, rodent urine stains, rodent hair, and gnawed packaging based on samples taken from your facility during the inspection.
Our investigation of the general conditions in the spice processing and storagefacility revealed: approximate 1" x 10" and 2" x 4" openingsto the outdoors at the bottom of the northeast comer door and approximate 1"x 3" and 2" x 3" openings to the outdoors at the bottom of thesouthwest comer door. In addition, our investigators documented a can of insecticide([redacted]) stored adjacent to finished product in your spice processing an
The above listed violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to insure that your facility is operated in a sanitary manner.
We are aware that on January 21, 2003, you voluntarily destroyed a 50 pound sack of blue poppy seeds, a 50 pound sack of black pepper, a 50 pound sack of meat tenderizer, and two, 50 pound sacks of whole ground mustard. We are also aware that you made promises to our investigators during the inspection to correct some of the observed deficiencies.
At the conclusion of the inspection, our investigators presented to you a list of deficiencies on a Form FDA 483, Inspection Observations. You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further informal notice. Such actions may include the initiation of seizure, injunction, or prosecution actions in federal court.
You should notify this office, in writing, within 15 days of receipt of this letter, of the steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 days, please state the reason for the delay and the time by which the corrections will be completed.
Your response should be directed to Rebecca A. Asente, Compliance Officer, U.S. Food and Drug Administration, 6600 Plaza Drive, Suite 400, New Orleans, Louisiana 70127. Should you have any questions concerning the contents of this letter, you may contact Ms. Asente at (504) 253-4519.
Sincerely,
/s/
F. Dwight Herd
Acting District Director
New Orleans District
