Inspections, Compliance, Enforcement, and Criminal Investigations
Universal Blanchers LLC
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3145
June 9, 2009
Michael Fischer, CEO
Universal Blanchers LLC
103 Westpark Drive, Ste. E
Peachtree City, GA 30269
Dear Mr. Fischer:
On February 18-26, 2009, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your peanut roasting facility located at P.O. Box 198, Highway 6 West, Dublin, Texas 76446. The inspection included the collection of environmental samples at various locations within your processing facility to be analyzed for the presence of Salmonella.
FDA laboratory analyses of an environmental sample (FDA sample # 485315) collected from various locations within your firm's processing facility found Salmonella spp. in eight subsamples. These findings lead FDA to conclude that your firm's roasted peanuts have been prepared, packed or held under insanitary conditions whereby the peanuts may have been rendered injurious to health (Section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act)).
The inspection also revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Failure to manufacture foods in accordance with the requirements of 21 CFR 110 renders your firm's roasted peanuts adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] in that they have been prepared, packed, or held under insanitary 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 Current Good Manufacturing Practice regulation for foods through links in FDA's home page at www.fda.gov.
Our laboratory findings resulted in eight positive subsamples of Salmonella recovered from swabs taken at eight different locations within your facility. Each of these positive subsamples was further serotyped and determined to be Salmonella infantis (S. infantis). Pulsed Field Gel Electrophoresis (PFGE) testing determined that the eight isolates of S. infantis were indistinguishable from one another. The recovery of the eight indistinguishable S. infantis serotypes is a significant concern because this reveals the presence of the pathogen as a niche or potential resident organism in your facility. One of these subsamples was collected from the floor within 6 to 10 feet of where roasted peanuts are packaged, and there is no physical barrier between raw peanut handling and roasted peanut packaging to prevent cross-contamination.
FDA acknowledges your communication in a teleconference on March 11, 2009, that on March 4-5, 2009, you shut down your facility for cleaning, including scrubbing and scraping the oven. Further, in a March 12, 2009 e-mail, your firm provided reports that indicated that you put all of your roasted products produced at the Dublin Texas facility on hold as of Thursday March 5, 2009, when you received the positive Salmonella readings. This e-mail also stated that your firm expanded your On Hold procedure to include the process of awaiting environmental test results from (b)(4)
You also stated that you have increased the number of environmental samples you collect in each zone and increased the frequency of environmental testing from (b)(4) to (b)(4) However, these procedures may not be sufficient to identify all of the niche areas harboring this organism and eradicate it from the food processing environment. It is essential that you identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as are necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
Your firm also indicated that you are considering adding a "Separating Wall" isolating the "Raw Infeed" area of the roaster from all other plant areas. Although this proposed action may help protect against cross-contamination, it does not address the presence of Salmonella in your facility. Additionally, from March 13, 2009, through March 27, 2009, your firm provided data from finished product and environmental testing conducted by (b)(4) which indicate no Salmonella was found. Please note that these negative findings do not reverse or invalidate FDA's positive findings.
At the conclusion of the inspection, you were issued a Form FDA-483, which delineated significant sanitation deficiencies, including the following:
1. To comply with 21 CFR 110.35(d), all food-contact surfaces shall be cleaned as frequently as necessary to protect against contamination of food. Non-food-contact surfaces of equipment also should be cleaned as frequently as necessary to protect against contamination of food [21 CFR 110.35(d)(3)]. However, the following deficiencies were observed:
a. On 2/23/2009, FDA investigators observed a build-up of peanut meal and a substance that fluoresced under a black light on the buckets inside the elevator for the Sorter Bin in the roasting plant.
b. On 2/18/2009, FDA investigators observed a black, crusty build-up about one inch thick on areas inside of the roasting oven, including.
the oven's ceiling in Cooking Zones (b)(4) and (b)(4) and on the oven doors in Cooking Zone (b)(4). Throughout the inside of the roasting oven, there was a rust-colored accumulation on the oven ceiling, walls, and beams in Cooking Zones (b)(4) through (b)(4)
c. On 2/18/2009, FDA investigators observed that the bristles on a brush used to clean the food-contact surface of the conveyor belt had an accumulation of a brown shiny substance.
2. To comply with 21 CFR 110.20(b)(7), you must provide adequate screening or other protection to protect against pests, and, to comply with 21 CFR 110.35(c), you must exclude pests from all areas of your food plant. However, the following deficiencies were observed:
a. On 2/18/2009, FDA investigators observed gaps between the loading doors and the floor in the roasting plant.
b. On 2/18/09 and 2/24/09, FDA investigators observed that the middle bolt lock on the door of Air Handler (b)(4) was not latched, leaving a 1/4-inch gap, and that there was a 1/8-inch gap in the door when latched. FDA investigators also observed that the door of Air Handler (b)(4) was not latched, and that there was a 4x4-inch gap in the screen covering the slotted vents in the air handler. In addition, on 2/18/09, FDA investigators observed forty-two (42) apparent rodent pellets inside Air Handler (b)(4).
3. To comply with 21 CFR 110.20(a)(1), you must remove litter and waste within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests. However, on 2/20/09, FDA investigators observed five inches of red skins used as mulch on the grassy area between the roasting plant and the blanching plant. According to your Trap and Bait Station location map, two rodents were caught near this mulch location.
This letter does not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your reply should be directed to Sherrie L. Krolczyk, Compliance Officer, at the address indicated on the letterhead.
Reynaldo R. Rodriguez, Jr
Dallas District Director
cc: Thomas Kevin Gaines, VP Southwest Operations
Universal Blanchers LLC
P.O. Box 198, Highway 6 West
Dublin, Texas 76446
Susan E. Tennyson, Director
Environmental and Consumer Safety Section
Department of State Health Services
P.O. Box 149347 Mail Code 2833
Austin, Texas 78714-9347