Inspections, Compliance, Enforcement, and Criminal Investigations
Sir Pizza of Tennessee, Inc. 2/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Building 200, Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
February 27, 2012
WARNING LETTER NO. 2012-NOL-14
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Nona G. Poole, President
Sir Pizza of Tennessee, Inc.
830 Old Salem Road
Murfreesboro, Tennessee 37129-4943
Dear Mrs. Poole:
On January 3-6, 2012, a U.S. Food and Drug Administration (FDA) investigator inspected your pizza restaurant commissary, located at 830 Old Salem Road, Murfreesboro, Tennessee. The inspection revealed serious violations of FDA's Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These conditions cause the food products held at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act and its implementing regulations through links on FDA's Internet homepage at www.fda.gov.
The significant violations were as follows:
1. Your firm failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator observed the following:
There was evidence of widespread rodent activity in, on, and near foods stored in your food processing facility, including the warehouse, packing room, and ingredient store room. For example:
Dough Production Room/Cardboard Pizza Rounds Storage Area:
• Two dead rodents on the floor in the northwest comer of the corrugated cardboard pizza rounds storage area. The dead rodents were observed under the metal frame storage rack holding uncovered corrugated cardboard pizza rounds used as packaging for uncooked pizza dough; and,
• Two apparent rodent excreta pellets (aREPs) on the metal frame storage rack along the north wall immediately adjacent to uncovered corrugated cardboard pizza rounds being stored on the rack.
Water Heater/Storage Area:
• Two dead rodents on the floor in the northeast comer directly behind the water heater; and,
• Approximately 30 aREPs on the floor in the southeast comer, north of the chase wall adjacent to the water heater.
Dry Storage Area:
• One aREP on a 50 lb. bag of (b)(4) located on a wire storage rack along the west wall approximately 4' from the entrance to the dock staging area and dough production room;
• At least 80 aREPs on the floor in the southeast comer and located approximately 12" from a rack holding plastic gallon containers of (b)(4)
• At least 50 aREPs on the floor along the east wall directly under a storage rack holding cardboard packaging materials for uncooked pizza dough;
• At least 35 aREPs on the plywood covered storage rack along the east wall immediately adjacent to cardboard packaging materials for uncooked pizza dough;
• At least four aREPs on the plywood covered storage rack along the east wall immediately adjacent to cardboard boxes holding empty plastic gallon containers used for packaging of manufactured marinara/spaghetti sauce and blue cheese dressing;
• At least 15 aREPs on the floor in the southwest comer directly under a wire storage rack holding food, including a case of artificial sweetener; and,
• At least 20 aREPs on the floor in the northwest corner approximately 12" below and approximately 2' north of 1-50 lb. bag of (b)(4) and 1-50 lb. bag of (b)(4)
2. Your firm failed to maintain food processing equipment in a sanitary condition to prevent food from becoming adulterated, as required by 21 CFR 110.35(d). Specifically, our investigator observed the non-food contact surfaces of the dough former/roller machine to be heavily soiled and covered with adhering oil, flour, and debris after production on January 3, 2012, and during the-production of pizza dough on January 4, 2012. The rollers of the conveyor and the area immediately adjacent to the conveyor belt also had a layer of brown oil and debris. Additionally, the conveyor belt used to transport rolled pizza dough balls was visibly soiled and frayed.
3. Your firm failed to construct your facility in such a manner that floors, walls, and ceiling may be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR 110.20(b)(4). Specifically, the damaged and pitted concrete floor, approximately 4" x 4' and 3/4" deep, was observed along the east wall immediately adjacent to the doorway to the dough production area and adjacent to an unused floor stand mixer. Standing water was observed in the damaged floor after production clean-up on January 3, 2012, and after production resumed the morning of January 4, 2012.
4. Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 11 0.35(a). Specifically, our investigator observed several walls in the dough production area which were heavily soiled and coated with debris in the following areas:
• The wall above and under the utility sink, the dough mixer, hand wash sink, and paper towel dispenser in the northwest comer of the room appeared to be heavily soiled and covered with debris; and,
• The wall behind the metal frame rack holding cases of pizza dough mix in the northeast comer was observed to be heavily soiled with black particles.
5. Your firm failed to properly store toxic compounds, as required by 21 CFR 110.35(b)(2). Specifically, at least eight exposed green rodent bait blocks, approximately 1" in diameter, were observed in the following areas in the facility:
Dry storage area
• Two exposed bait blocks under the food storage shelf located in the southwest corner of the room directly under a case of artificial sweetener; and,
• Three exposed bait blocks under the food/packaging storage shelf located along the east wall directly under packaging materials for pizza dough, marinara/spaghetti sauce, and blue cheese dressing manufactured at the facility.
Storage area in the dough production area
• Two exposed bait blocks under the packaging storage shelf located along the east wall directly under stacks of round corrugated cardboard trays used in the packaging of uncooked pizza dough.
Water Heater/Storage Room
• One exposed bait block located in the southeast comer north of the chase wall adjacent to the water heater. The bait block was surrounded by apparent bait block granules covering an approximate area of 5" x 8".
The FDA has determined your facility is subject to the registration requirement in Section 415 of the Act, (21 U.S.C. § 350d), and our implementing regulation at 21 CFR Part 1, Subpart H. During the current inspection of your facility, you were advised of this requirement. Failure to register a facility as required, is a prohibited act under Section 301(dd) of the Act, [21 USC § 331 ( dd)]. Our records indicate, to date, your facility has not been registered with FDA.
The above listed violations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure your facility is operated in a sanitary manner. At the conclusion of the inspection, the FDA investigator presented to you a list of deficiencies on a FORM FDA 483, Inspection Observations. We are aware of your firm's voluntary corrective actions in response to the inspection and conducted as our investigator brought violative conditions to your firm's attention. Specifically, we note you voluntarily destroyed 1-50 lb. bag of (b)(4). The bag was observed to have an adhering rodent pellet and fluorescing apparent urine stains on the bag. The holes in the exterior and interior of the facility were observed to be sealed with expanding foam sealant. You should continue to take prompt action to correct these violations. Failure to promptly correct and prevent the recurrence of these deviations may result in regulatory action such as a seizure or injunction.
Please respond in writing within 15 working days of your receipt of this letter outlining the additional steps you have taken to bring your firm into compliance with the law, including steps taken to correct the violations and prevent their recurrence. You should include in your response documentation, such as written procedures, and other useful information, to assist us in evaluating your corrective actions. If corrective action cannot be completed within 15 working days, we expect you to explain the reason for the delay and state when the remaining deviations will be corrected.
We request you register your facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, you may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. Are-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j- 31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Mark W. Rivero, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1103.
Patricia K. Schafer
New Orleans District