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U.S. Department of Health and Human Services

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Enforcement Actions

Imperial Trading Company, Inc. 19-Nov-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Southeast Region
New Orleans District
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217

Telephone:(615)366-7801
FAX: (615)366-7802


November 19, 2007

WARNING LETTER NO, 2008-NOL-04

FEDERAL EXPRESS
OVERNIGHT DELIVERY

John D. Georges, Sr., CEO
Imperial Trading Company, Inc.
701 Edwards Avenue
Harahan, Louisiana 70123

Dear Mr. Georges:

On September 10-13, 17-18, and 21, 2007, U.S. Food and Drug Administration (FDA) investigators inspected your multiple food storage facility, located at 701 Edwards Avenue, Harahan, Louisiana. 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, Part 110. During the inspection, our investigators documented numerous insanitary conditions, which caused the finished food products held at your facility to become adulterated. The adulterated food products are in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act as they have been held under insanitary conditions whereby they may have become contaminated with filth.

Evidence of widespread rodent activity was observed in, on and near foods stored in your multiple food storage facility, including both the dry goods warehouse and cooler. This evidence included live and dead rodents, rodent excreta pellets, and gnawed food packaging. Evidence of rodent gnawing and general rodent activity was observed on and around, several different food products including, but not limited to, various candy and snack food products and chocolate milk. Our FDA laboratory confirmed the findings of rodent excreta pellets, rodent hair, and gnawed packaging based on samples taken from your facility during the inspection.

Our investigation of the general conditions in the storage facility revealed: approximate 1/2" x 1/2" gaps on the left bottom side and 1/4" x 2 1/2" gaps on the right bottom side of the closed east wall emergency door, which leads directly to the outdoors; gaps along the north wall-floor juncture near the dry storage area ranging from 1/4" to 1" x 1 3/4" to 18"; gaps in walls revealing insulation on the east wall of the candy cooler; crowded and unorganized storage of equipment, construction material, and debris; trash throughout; boxes of food stored directly against cooler walls; storage shelves with boxes of food situated less than 5" from the warehouse walls; boxes of food stored directly on the warehouse floor; and tall grass within the immediate vicinity of the outer building. Our investigators observed at least [redacted] loading dock doors remained open during the inspection. Also, our investigators observed a pallet of damaged containers of fruit punch, which had leaked onto the pallet and surrounding boxes, remained overnight in the cooler. The pallet was cleaned u the next day, on September 18, 2007, after FDA investigators notified management.

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.

At the conclusion of the inspection, our investigators presented to Mr. Wayne M. Baquet, Jr., President, a list of deficiencies on a Form FDA 483, Inspection Observations. You should continue to take prompt action to correct these violations. Failure to promptly correct and prevent the recurrence of these deviations may result in regulatory action such as a seizure or injunction.

We are aware of your firm's voluntary corrective actions in response to the inspection and conducted as our investigators brought violative conditions to your firm's attention. We note, on September 18, 2007, your firm voluntarily destroyed approximately [redacted] worth of food products, which had been stored in the cooler. We are also in receipt of Mr. Baquet's September 25, 2007, response to the September 21, 2007, Form FDA 483.

Please respond in writing within 15 working days of your receipt of this letter outlining the additional steps you have taken to bring your firm into compliance with the law, including steps taken to correct the violations and prevent their recurrence. You should include in your response documentation, such as written procedures, and other useful information to assist us in further evaluating your corrective actions. If corrective action cannot be completed within 15 working days, we expect you to explain the reason for the delay and state when the remaining deviations will be corrected.

Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer, at the above address. Should you have any questions concerning the contents of this letter, you may contact Ms. Asente at (504) 219-8818 extension 104.

Sincerely,

/S/

Carol S. Sanchez
Acting District Director
New Orleans District

Enclosure: Form FDA 483, dated September 21, 2007

cc: Wayne M. Baquet, Jr., President
Imperial Trading Company, Inc.
701 Edwards Avenue
Harahan, Louisiana 70123