Inspections, Compliance, Enforcement, and Criminal Investigations
80 Million Food 25-Mar-03
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
RETURN RECEIPT REOUESTED
Mr. Young Kwon Kim, President
80 Million Food
4539 N. Pulaski Rd.
Chicago, IL 60630
Dear Mr. Kim:
The U. S. Food and Drug Administration (FDA) conducted an inspection of your firm, 80 Million Food, located at 4539 Pulaski Rd., Chicago, Illinois, January 6/21, 2003. During the inspection, the investigators found you were processing fresh and dried seafood in making your ready-to-eat kimchi products and have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, renders the fishery products adulterated within the meaning of Section 402(a) (4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). Accordingly, some of your kimchi products are adulterated, in that the kimchi with seafood products have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP Regulations through links in FDA’s home page at www.fdagov .
The deviations observed by the investigators were as follows:
- Concerning your ready-to-eat kimchi products you make with seafood, you must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are reasonable likely to occur, to comply with 21 CFR 123.6 (a) and (b). However, your firm does not have a HACCP plan for kimchi products with seafood to control the food safety hazard of botulism and other pathogens.
- Your firm lacks standard sanitary operating procedures (SSOPs). The investigators observed numerous poor food handling practices and conditions in the facility that are serious deviations from the Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food referenced under 21 CFR 110. Also, as a part of HACCP, you must adequately monitor sanitation conditions and practices during processing, especially when preparing ready-to-eat products such as your kimchi, to comply with 21CFR 123.11 (b). Serious deficiencies observed during the inspection included:
- Employees were not washing or sanitizing hands upon entry/re-entry to process areas after performing other tasks.
- Employees wearing rubber gloves were handling equipment and water hoses and did not clean or sanitize gloves prior to handling raw food products.
- Gloves used in food handling were soiled and stored haphazardly on a cabinet top with labels, hats, and other miscellaneous items.
- Employee eating kimchi from finished product with bare hands and then putting their hands back into the finished kimchi product.
- No soap or sanitizing solutions were provided in the restroom or at stations in the food production areas.
- Restroom door remains open when not in use.
- Use of old soiled plastic/fabric aprons by production help, in which the plastic was flaking off.
- Protective hair covering was not in use in production areas.
- Light fixtures over production areas did not have protective covers.
- There were no sanitizing solutions in use or available to clean food handling equipment/utensils for several days.
- In-process products were in open exposed containers or racks at room temperature for long periods of time (in excess of 8 hours).
- Floor drains were clogged with debris causing standing water in production areas.
- Water hoses on floor exposed to debris and standing water.
- Black mold or mildew like substance was growing on ceiling/walls in different areas of storage/production.
- Doors to the exterior were poor fitting with gaps 1/2 inch at the base and more on sides.
- Rodent excreta pellets in the cooler around food products.
- An insect infested lot of rice was being held in the cooler.
The above-listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence to each requirement of the Act, and its implementing regulations, including being vigilant that products you manufacture and distribute meet all of the applicable laws and regulations. We request that you take action to correct all violations. Failure to promptly correct these violations may result in regulatory action without further notice, including seizure and/or injunction.
During the inspection, we note that you voluntarily destroyed the insect infested rice in your cooler. We understand that you have attended a Seafood HACCP training course since the inspection. Please provide this office, within 15 working days of receipt of this letter, a detailed response in writing that states the actions you plan to take, or have taken, to correct and prevent the objectionable conditions we have cited. Provide the specific time within which corrections will be completed, reasons why any corrective action cannot be completed, and documentation (HACCP plan, monitoring forms to be used, corrected labels), etc. to show that corrections have been made.
In addition to the above conditions, the investigators determined that ingredient statements on labels may not always be accurate with what was observed during processing, i.e., seafood used in kimchi products was not declared on the labels for the products or there was conflicting information regarding what ingredients were to be included in products. Product labels must accurately show product content among other things to be in compliance with the Act. Labeling requirements are also addressed in links to the FDA home page referenced at the beginning of this letter.
Please direct your reply to Paul A. Boehmer, Compliance Officer, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661.
Arlyn H. Baumgarten