| Public Health Service Food and Drug Administration |
Atlanta District Office |
Department of Health and Human ServicesJuly 15, 2011
VIA UNITED PARCEL SERVICE
William D. Toler, CEO/President
Advance Pierre Foods
9990 Princeton Glendale Road
Cincinnati, OH 45246
WARNING LETTER
(11 – ATL- 14)
Dear Mr. Toler:
On March 8-11, 2011, the U. S. Food and Drug Administration (FDA) inspected your food manufacturing firm located at 133 Clovervale Drive in Easley, SC. This establishment inspection was initiated as a follow-up to a Reportable Food Registry (RFR) notification, reporting that your Pierre PB Jamwich peanut butter and strawberry jam products were found positive for Listeria monocytogenes (L. monocytogenes). During our inspection, finished product, in-line, and environmental samples were collected. Laboratory analysis of environmental swabs (sample 640163) confirmed the presence of L. monocytogenes in your facility. In addition, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for food found in Title 21 of the Code of Federal Regulations (CFR) Part 110 (21 CFR 110). Collectively, these violations and the noted sample results render the food products manufactured in your facility adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) § 342(a)(4)], in that the products were 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 pertinent FDA regulations through links on FDA’s website at www.fda.gov.
L. monocytogenes is a widespread pathogenic bacterium that without proper controls may be introduced into and proliferate in food manufacturing facilities whereby it may contaminate food. Consuming foods that are contaminated with L. monocytogenes may lead to a mild, non-invasive illness known as listerial gastroenteritis or a more severe, sometimes life-threatening, illness known as invasive listeriosis. Pregnant women and their unborn children, infants, the elderly, and persons with weakened immune systems are of greatest risk of experiencing listeriosis, which is characterized by a high case mortality rate and long incubation.
Two locations within your peanut butter and jelly sandwich processing room tested positive for L. monocytogenes during the current inspection. These positive environmental swabs (collected as part of sample 640163) were collected from standing water underneath the left side of the peanut butter heating kettle and on the floor (including the crevice of a man-hole cover) beneath the hand washing sink’s rubber mat .
FDA collected environmental swabs (sample 470403) during the previous establishment inspection, conducted May 17-19, 2010, revealing L. monocytogenes in three locations within your facility. Those locations, non-food contact surfaces including a dustpan handle, a floor drain, and pooled water in a corner of the entrance, were also within your peanut butter and jelly sandwich processing room.
FDA also collected L. monocytogenes isolates that had been found in your finished Pierre PB Jamwich peanut butter and strawberry jam product, leading to the report in the RFR. Those Listeria isolates were collected for comparison to L. monocytogenes isolates from the positive environmental swabs collected during the previous and the current inspections. Analysis using pulsed-field gel electrophoresis (“PFGE”) showed that the L. monocytogenes strains found during the previous inspection, the current inspection, and in the finished product are all indistinguishable from one another. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that the two isolates are the same strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported and established in niche areas in your peanut butter and jelly sandwich processing room.
Further, the presence of a persistent strain of L. monocytogenes in your peanut butter and jelly sandwich processing room between May 2010 and March 2011 is significant in that it demonstrates that your cleaning and sanitation efforts were inadequate to remove this organism and may allow for contamination of foods with pathogens.
In addition, FDA investigators observed the following serious violations of the Current Good Manufacturing Practice (CGMP) regulations:
1. You did not maintain buildings and fixtures in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Specifically:
• The parts washing sink, located within five feet of the peanut butter sandwich line A, was observed leaking water at the faucet and at the water feed line to the faucet from the leg pedals beneath the sink. Wet footprints were observed leading from the production room into the adjacent warehouse area and then traveling back into the production room.
• Standing water was observed below the peanut butter steam/heating kettle, due to a water leak at a fixture attached to the left side of the kettle for the hot water feed.
• Water was observed leaking from the sherbet pasteurization tank onto the floor.
• Standing water was observed around the hand washing sink located in the peanut butter and jelly sandwich processing room.
• Standing water was observed around the hand washing sink located just outside of the entrance to the peanut butter and jelly ice cream sandwich / graham cookie room.
• Standing water was observed beneath pallets of packing material along the north wall of the warehouse.
2. Your plant is not constructed in a manner to allow floors and walls to be adequately cleaned and kept clean and kept in good repair as required by 21 CFR 110.20(b)(4). Specifically:
• The floor located in the peanut butter and jelly sandwich processing room was pitted and contained low areas that allow water to pool.
• Concrete floor expansion joints located in the peanut butter and jelly sandwich processing room were cracked, allowing the accumulation of water and debris.
• Stainless steel equipment guards in the peanut butter and jelly sandwich processing room allow water to drain/seep below and pool along the walls.
• The floor in the peanut butter and jelly ice cream sandwich / graham cookie room is unlevel and allows water to pool.
This letter is not intended to be an all-inclusive list of violations that may exist at your food manufacturing facility. You are responsible for ensuring that your firm is operating in compliance with all requirements of the Act and pertinent FDA regulations, such as the food CGMP regulations. You should take prompt action to correct all of the violations noted in this letter and to establish and implement procedures that will prevent such violations from occurring in the future. Failure to implement lasting corrective action may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
We acknowledge receipt of the March 26, 2011, written response to the FDA 483 from your quality assurance manager, Gabriella Iwuchukwu. A copy of the FDA 483 issued to Robert A. Barron, Plant Manager, is enclosed for your review. The response does not address the steps taken to prevent the accumulation of standing water in your facility (such as sloping floors toward drains, assessing unlevel floors, or eliminating low areas that allow water to pool on the floor), or modifications to your cleaning and sanitizing operation to address our finding of a persistent strain of L. monocytogenes in your facility between May 2010 and March 2011. In addition, with respect to some of the corrective actions described in the response, the response does not provide sufficient detail and documentation for FDA to evaluate the adequacy of the corrections. Specifically, the response stated that you had relocated the hand washing sink that we had observed in the peanut butter and jelly sandwich processing room during the inspection. During the inspection closeout, Mr. Barron proposed that this sink would be relocated just outside of the peanut butter and jelly sandwich processing room. However, the response does not specifically identify whether this is the location to which the sink was moved. The response does not identify the sink’s current proximity to any products or production lines. Similarly, the response states that the part wash sink has been relocated, but the response does not specify the new location of that sink and its proximity to any products or production lines. Furthermore, the response states that there are plans to modify the area of the leak in your sherbet pasteurization tank, but the response does not indicate the manner in which that piece of equipment is to be modified.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrections have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the correction(s).
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
Sincerely,
/s/
John Gridley
District Director
Atlanta District Office
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