|Subject:||Current Good Manufacturing Practice Regulations for Human Foods/Adulterated|
|Issuer:||Chicago District Office|
|Issued:||Nov. 10, 2010||Closed:||April 4, 2012|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
November 10, 2010
RETURN RECEIPT REQUESTED
Thomas E. Werer
3661 South Iron Street
Chicago, Illinois 60609
Dear Mr. Werer:
From April 13 through June 25, 2010, the Food and Drug Administration (FDA) inspected your food manufacturing firm located at 3661 South Iron Street in Chicago, Illinois. During the investigation we collected samples consisting of environmental swabs. The results of the analysis of the environmental swabs, sample number 611088, found the presence of the pathogen Listeria monocytogenes in your facility. In addition, we found significant violations of FDA's Current Good Manufacturing Practice (CGMP) requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) at your facility. These violations cause the food products manufactured in your facility to be 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's website at www.fda.gov .
Our inspection of your facility revealed the following violations of the CGMP regulation (21 CFR Part 110):
1. You must manufacture, package, and store foods under conditions and controls necessary to minimize the potential for the growth of microorganisms and for the contamination of food to comply with 21 CFR 110.80(b)(2), However, environmental samples from the floor in your processing room found Listeria monocytogenes , which may colonize wet food processing facilities, especially where organic debris is present. Listeria monocytogenes is a pathogenic bacterium that can contaminate foods, resulting in a mild illness called listerial gastroenteritis or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to listeriosis. High pressure sprays such as those that your firm uses to clean the processing area are reasonably likely to contaminate food contact surfaces with Listeria monocytogenes from the floor.
2. You must maintain your production area in a sanitary condition to comply with 21 CFR 110.35(a) to prevent food from becoming adulterated within the meaning of the Act. However, during the inspection, an employee was observed removing a used toilet seat lid from an employee restroom and placing it on the hand washing sink adjacent to the production area where ready-to-eat vegetables are processed.
3. You must conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials to comply with 21 CFR 110,35(a). However, following your daily cleaning, organic debris resulting from mushroom processing persisted throughout the processing area, on conveyor belts, on packaging material, on the mushroom slicer and on the ceiling and light fixtures above the mushroom slicer.
4. Buildings, fixtures, and other physical facilities must be maintained in a sanitary condition and kept in repair sufficient to prevent food from becoming adulterated to comply with 21 CFR 110.35(a). However, our investigators observed the following:
> Missing ceiling tiles and ceiling tiles with water damage and mold like growth in the production area.
> Water dripping directly onto fresh sliced mushrooms, and water dripping on and near other food and food contact surfaces.
5. You must equip your plant with adequate toilet facilities to comply with 21 CFR 110.37 (d). However our investigators observed the following:
> You did not provide doors that do not open into areas where food is exposed to airborne contamination. Both restroom facility doors open directly into the area where, fresh-cut, ready to eat raw mushrooms, vegetables and fruits are processed and neither restroom facilities have exhaust fans.
> Ceiling tiles were missing entirely in the restrooms exposing the concrete aggregate ceiling directly below the roof. Visual signs of leaking water and water stains were observed on the ceiling.
> A waste floor drain for a previously installed urinal was exposed in the men's employee restroom. A strong sewer like odor was apparent in the area. During the inspection, a toilet brush cleaner was observed placed inside the exposed waste floor drain.
> Standing water was observed on the floor of the men's restroom.
6. You must maintain food contact surfaces such that food is protected from contamination from any source to comply with 21 CFR 110.40(a) to protect food, however:
> A dust broom and red plastic shovel, used for cleaning in the production area, were observed on top of a pallet of 5 pound plastic pails after the firms' daily cleaning procedure. The same or similar pails were stacked on the floor next to the mushroom slicer. These pails are used to contain sliced ready to eat mushrooms.
> Several empty mushroom boxes were observed stored on the floor of the Box Room. The boxes are used in the packaging of freshly sliced raw ready to eat mushrooms.
7. You must construct your plant in a manner to prevent drip and condensate from fixtures, ducts, and pipes from contaminating food, food-contact surfaces, and food-packaging materials to comply with 21 CFR 110.20(b)(4). However, condensate was observed dripping from the ice machine and ice machine stand onto the ice stored below. The condensate was dripping from surfaces on the ice machine stand which contained rust-like, mold-like, and dirt-like residues. The ice is placed directly onto raw ready to eat sliced produce for distribution.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
If you have any questions about the content of this letter please contact Rosemary Sexton, Compliance Officer, at 312-596-4225 or firstname.lastname@example.org .