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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Doerle Food Services Inc. 13-Jan-03

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration
New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, LA 70127
Telephone: 504-253-4500
Facsimile: 504-253-4560

January 13, 2003

WARNING LETTER NO.2003-NOL-07

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Ms. Carolyn Doerle, President/CEO
Doerle Food Services Inc.
401 W. Admiral Doyle Avenue
New Iberia, Louisiana 70562

Dear Ms. Doerle:

The U.S. Food and Drug Administration (FDA) inspected your food storage warehouse facility, located at 401 W. Admiral Doyle Avenue, New Iberia, Louisiana, during October 24 - November 5, 2002. 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 investigator documented numerous insanitary conditions, which caused the food products stored 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 (the Act), in that they have been held under insanitary conditions whereby they may have become contaminated with filth.

Evidence of rodent and bird activity was observed on and near foods stored in your warehouse. This evidence included rodent excreta pellets, rodent-gnawed food packages, and bird excreta droppings. Evidence of bird excreta droppings was observed on the surfaces of food containers for several different food products, including grape juice, sugar, and seasoning. Evidence of rodent activity was observed on and around food products, including yellow corn meal and sugar. Our FDA laboratory confirmed the findings of rodent excreta, rodent-gnawed packaging, and bird excreta droppings sampled from your facility during the inspection.

Our investigation of the warehouse revealed: live birds perched on product, racks, pipes, and roof structural supports in the main storage area of the facility; unscreened or, otherwise, unprotected, dock doors and roof vents open throughout operations on October 24, 25, and 28, 2002; and, stagnant water present around the loading docks of the storage facility.

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 investigator presented to you a list of deficiencies on a Form FDA 483, list of 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 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 Cynthia R. Cracker, Compliance Officer, U.S. Food and Drug Administration, 100 W. Capitol Street, Suite 340, Jackson, Mississippi 39269. Should you have any questions concerning the contents of this letter, you may contact Ms. Cracker at (601) 965-4581.

Sincerely,

/s/

Carl E. Draper

District Director

New Orleans District