Inspections, Compliance, Enforcement, and Criminal Investigations
Reserve Marine Terminals 22-May-02
Food and Drug Administration
300 S. Riverside Plaza, Suite 550 South
Chicago, Illinois 60606
May 22, 2002
RETURN RECEIPT REQUESTED
Reserve Marine Terminals
11401 S. Green Bay Avenue
Chicago, IL 60617
Dear Mr. Joseph:
An inspection of your food-storage warehouse, located at 12800 S. Butler Drive, Chicago, IL, by the Food and Drug Administration (FDA) on March 25, 26, and 28, and April 2, 2002, documented numerous insanitary conditions at this facility. The inspection was conducted at the request of the U.S. Department of Agriculture, Federal Grain Inspection Service (FGIS), following their report of rodent urine-stained and rodent-gnawed product bags at this site, which stores products manufactured under USDA contract for international relief programs. At the conclusion of the inspection, you were issued a Form FDA 483, which is a list of our investigators? observations of deviations noted during the inspection. (A copy of the FDA 483 is enclosed.) Samples of rodent evidence from products/storage areas were also collected for analysis as part of the inspection.
The insanitary deficiencies identified during our inspection include serious deviations from FDA?s Good Manufacturing Practice Regulations for Manufacturing, Packing or Holding Human Food, which are contained under Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These deviations cause products you store to be adulterated, within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). They are adulterated because they have been prepared, packed or held under insanitary conditions whereby they may have been contaminated with rodent filth. (You can find this Act and the Good Manufacturing Practice Regulations through links in FDA?s home page at http://www.fda.gov).
Specifically, our determinations and the deviations we observed during our inspection are a follows:
- Effective measures are not being taken to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
- Rodent-gnawed holes into product were observed in twelve bags of CORN SOY BLEND, located on eight different pallets in the northeast comer/end of your warehouse.
- Rodent urine stains were observed on five bags of CORN SOY BLEND, located on a pallet that also contained bags with rodent-gnawed holes, in the northeast comer of the warehouse.
Our lab confirmed rodent-gnawed holes and rodent urine stains, collected from bags of CORN SOY BLEND, as part of our inspection.
- A rodent burrow hole was observed at the floor/wall juncture inside the southwest part of the warehouse, and another hole leading under the north wall of the warehouse was observed outside.
- A live bird was seen on top of a pallet of CORN SOY BLEND in the northeast comer of the warehouse.
- Wet dog feces were observed in the north central part of the warehouse, approximately twenty feet from bags of CORN SOY BLEND.
Your firm has failed to keep buildings and physical facilities in repair, sufficient to prevent food from becoming adulterated, in order to comply with 21 CFR 110.35(a).
- A gap was observed under a pedestrian doorway on the west side of the warehouse, and under a second pedestrian doorway and a dock door on the warehouse?s east side. The gaps, which are potential rodent ingress/egress points, are within two feet, ten feet and twenty feet respectively of pallets of dried milk in paper bags.
- Two dock doors (on the east and west side of the warehouse) were open during the inspection, and are within twenty feet and approximately twenty-five feet respectively of corn soy blend in paper bags. A hole in a glass window above a door on the west side of the warehouse is within approximately two feet of paper bags of dried milk.
Your firm has failed to properly store equipment inside your facility, and remove litter/waste and excess shrubbery within the immediate vicinity outside, that may constitute an attractant, breeding place, or harborage area for pests, as required by 21 CFR 110.20(a)(1).
- Excess, unused equipment (wood, pallets, steel beam parts) with some unidentified product were observed on the floor at both the north and south end of the warehouse.
- Garbage food products were observed directly outside the firm.
Your firm has failed to provide adequate lighting where food is examined, stored, or processed, in order to comply with 21 CFR 110.20(b)(5).
The above-listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence with each requirement of the federal regulations. Our investigators reported that you voluntarily destroyed all corn soy blend on hand, and destroyed physically damaged bags of dry milk. They also reported that you have repaired holes and gaps in your structure, covered rodent burrows, closed open doorways, cleaned the warehouse and disposed of all excess equipment. Additionally, you have removed garbage outside the vicinity of your building, and contracted your pest control company to perform more service inside the warehouse. Other corrections have been promised.
While we acknowledge these corrective actions, your response to insanitary conditions in the current inspection should include a specific, comprehensive approach to monitor and prevent insanitary conditions and practices from rendering your product storage and other operations out-of-control.
We request that you take prompt action to correct any remaining violations and implement a systematic plan for ensuring that your operations are controlled.
Please provide this office, within 15 working days of receipt of this letter, a detailed response stating the actions you plan to take to correct any remaining violations, and prevent the recurrence of all objectionable conditions. Provide the time within which any remaining corrections will be completed, reasons why any corrective action cannot be completed, and documentation to show that corrections have been made. Failure to take prompt action to correct all violations may result in regulatory action without further notice. Such action may include seizure and/or injunction.
Your reply should be directed to James T. Karpus, Compliance Officer at the Chicago District Office.
Arlyn H. Baumgarten