Triple A Services, Inc. 4/20/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
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April 20, 2011
RETURN RECEIPT REQUESTED
Mr. Scott C. Whennen, President
Triple A. Services, Inc.
2637 S. Throop Street
Chicago, IL 60608
Dear Mr. Whennen:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing and storage facility, located at 2637 S. Throop Street, Chicago, Illinois, 60608, between January 5 and January 21, 2011. During the inspection, we documented serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the 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)] because the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and the regulations through links in FDA's homepage at www.fda.gov.
FDA acknowledges the receipt of your response to the Form FDA-483 dated February 8, 2011. However, this response did not adequately address the CGMP violations observed by our investigators during the inspection, as discussed further below.
1. Your firm failed to take effective measures to exclude pests from the processing areas and protect against contamination of food by pests, as required by 21 CFR 110.35(c). Specifically:
- A small bird was perched on a ceiling support directly above a hot truck. The bird then defecated, and the excreta landed within 3 feet of the truck. The truck was unattended, and uncovered onion condiments were being stored on the back bumper of the truck. The ceiling support that the bird was perched on was covered in apparent bird excreta.
- A black and white cat was inside the facility towards the southeast corner of the South garage. The South garage was mostly empty, but enters directly into the Offices and Store of the facility, where finished products are held for truck drivers to pick up.
- Five large birds were on the floor in the northeastern corner of the Central garage walking near scraps of food left unattended on the floor.
- Three small birds were flying in the West garage, where hot trucks were holding uncovered food, some of which were unattended. The West garage opens directly into the Central garage.
- Three small birds were flying in the middle of the Central garage above where hot trucks were holding uncovered food, some of which were unattended.
- One large bird was walking around on the southeastern floor of the Central garage, and many birds could be heard chirping inside the facility. At the time, hot trucks were holding uncovered food and some were unattended. The bird was within 10 feet of the doorway of the Cart room.
- A cart holding finished pork tacos and various sandwiches had approximately 18 apparent bird excreta on top of it, and 10 apparent bird excreta on its lower shelf. This cart was parked outside of a hot truck unattended on the south side of the Central garage.
- An empty black crate had approximately 12 apparent bird excreta on it. Other crates had apparent bird excreta on them as well. The crates were stored on the east side of the Central garage, approximately 5 feet from the Cart room, and are used to store and transport finished ready-to-eat Fruit Plates, Eggs, Cheese & Crackers, and other products.
In your response letter dated February 8, 2011, you informed FDA that your firm has contacted an outside contractor who recommends an Electronic Sound Device. However, you did not indicate a proposed installation date, nor did you indicate that the device has been installed. Further, the letter did not include information describing additional pest control measures your firm has implemented to exclude pests from your facility. The pest control measures utilized by your firm before FDA's January 2011 inspection were not effective, as evidenced by the presence of pests within your facility. Your firm needs to take more aggressive pest control measures to eliminate pests from your facility and to prevent pests from entering your facility.
2. Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically:
- A bird flew in the door on the south side of the Central garage.
- Multiple doors were open at the southern sides of the West and Central garages, and the western side of the South garage.
- The northern ceiling of the Central garage had a gap approximately 10 feet long and 2.5 inches wide. Below the gap, trucks were parked, some of which were open and unattended.
- The northeast ceiling of Central garage had a gap approximately 6 inches long and 2.5 inches wide.
- Two dumpsters on the north and south side of the Central garage were uncovered, with food and other refuse inside. Birds were seen near these dumpsters on both days.
- The raw materials room, which holds flour and other bakery needs, had an open ceiling which leads directly into the hallway. A dock door is right outside this room, and a large bird was seen within 15 feet of this room.
As mentioned above, your response letter dated February 8, 2011, did not provide adequate information regarding the additional pest control measures your firm has implemented to exclude pests from your facility. The pest control measures utilized by your firm before FDA's January 2011 inspection were not effective, as evidenced by the presence of pests within your facility. Your firm needs to take more aggressive pest control measures to eliminate pests from your facility and to keep pests from entering your facility.
Also, although weather conditions will be taken into consideration in evaluating the timeliness of some of your corrections, weather conditions should not affect or delay the interior roofing/ceiling repairs to prevent pests from entering your facility. You did not submit timelines for repairs of the ceiling or raw materials room, and this information is necessary to evaluate the adequacy of your response.
3. Your plant equipment is not so designed and of such materials as to be adequately cleanable, and is not properly maintained, as required by 21 CFR 110.40(a). Specifically:
- Carts used to transport finished products, such as ready-to-eat Fruit Plates and ready-to-eat Eggs, Cheese & Crackers, are made of unfinished wood with an uneven surface. Many carts had bird-like excreta on them. The material does not ensure that they can be adequately cleaned, and the condition of the carts indicates that they are not properly maintained.
Your February 8, 2011 response letter indicates that all carts will be treated to ensure that complete and proper cleaning will be performed. However, you did not provide details of how you will ensure proper cleaning. We will verify the adequacy of your response concerning this violation during our next inspection.
4. Your plumbing is not of adequate design or adequately maintained to avoid creating an unsanitary condition, as required by 21 CFR 110.37(b)(3), or to provide that there is not backflow from, or cross-contamination between, piping systems, as required by 21 CFR 110.37(b)(5). Specifically:
- A black hose attached to the faucet of a 3-compartment sink in the production room was resting on the ground underneath the sink. This hose is used to rinse the surrounding area and floor during the cleaning process. There was no backflow prevention device between the hose and the faucet.
Your February 8, 2011 response letter indicates that your firm has contacted an outside contractor to perform the corrective actions necessary to address this violation; however, you did not indicate that you will provide employee training regarding proper placement and storage of the hoses in order to prevent recurrence of this violation. We will verify the adequacy of your response concerning this violation during our next inspection.
5. You failed to remove litter and waste and cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage area for pests, as required by 21 CFR 110.20(a)(1). Specifically:
- The area north of the Central garage, in immediate proximity of your facility, has not been well maintained and the weeds and grass have not been cut. This area may constitute an attractant for birds or other pests.
Your February 8, 2011 response letter indicates that your firm will clean the areas and remove the weeds as soon as the snow subsides; however, you have been cited for similar observations in past FDA inspections and any corrective actions from those inspections do not appear to have addressed this problem on a permanent basis. It is your responsibility to maintain your surrounding grounds to prevent harborage of pests that may gain entry to your facility. We will verify any corrective actions concerning this violation during our next inspection.
This letter is not intended to be an all-inclusive list of the violations at your firm. It is your responsibility to ensure that you operate your firm in compliance with the Act, the CGMP regulations, and all other FDA regulations. We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating.
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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, 550 W. Jackson, Suite 1500, Chicago, IL 60661. If you have questions regarding any issues in this letter, please contact Ms. Sexton at (312) 596-4225 or firstname.lastname@example.org
Scott J. MacIntire