Inspections, Compliance, Enforcement, and Criminal Investigations
DNO Inc 12/12/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
December 12, 2013
Via United Parcel Service
Anthony A. DiNovo
3650 E. 5th Ave.
Columbus, OH 43219-1805
Dear Mr. DiNovo:
The U.S. Food and Drug Administration (FDA) inspected your processed fruit and vegetable produce manufacturing facility, located at 3650 E. 5th Avenue, Columbus, OH, from August 1- 8, 2013. During our inspection, FDA collected an environmental sample consisting of multiple swabs collected from various areas within your processing facility. FDA laboratory analyses of the environmental swabs found Listeria monocytogenes (L. monocytogenes), a human pathogen, in ten of the eighty-eight swabs, including seven swabs from food-contact surfaces. These findings of L. monocytogenes in your processing facility cause your fruit and vegetable produce products 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 rendered injurious to health. You can find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Consumption of food contaminated with L. monocytogenes can result in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Invasive listeriosis occurs predominantly in older adults and persons with impaired immune systems. Listeriosis in pregnant women is typically a mild “flu-like” illness, but can result in fetal death, premature labor, or neonatal infection.
Prior to FDA’s inspection and collection of environmental swabs, we acknowledge that DNO, Inc. submitted a Reportable Food Registry (RFR) report on July 25, 2013. The RFR report was based on product sampling results from your third party laboratory that found L. monocytogenes in sliced zucchini product. We also acknowledge that on July 24, 2013, you voluntarily recalled all zucchini products sold between July 1-24, 2013, due to potential L. monocytogenes contamination.
On August 27, 2013, FDA notified you of our findings regarding the presence of L. monocytogenes in your processing facility. We acknowledge your written response, received on September 3, 2013, which described your corrective actions. Your response states, among other things, that you will wash all raw produce destined to become “ready to eat” (RTE) in (b)(4) prior to processing; sanitize all product contact surfaces with a solution of (b)(4) during each product change over and break; clean and sanitize all equipment daily; designate employees for sanitation responsibilities who will never come in contact with RTE product or contact surfaces; restrict access to processing areas; restrict use of hoses during processing; provide those who enter the processing area with waterproof footwear that must remain on the premises or with disposable shoe covers; restrict the use of cold weather gloves in the processing area; define and segregate areas for raw, repackaged, work-in-process, and RTE products; install an (b)(4) system for treatment and continuous monitoring of produce wash water; alter your environmental monitoring program to be more proactive in uncovering areas of microbial harborage; implement daily pre-operational testing to verify effective sanitation; develop a sanitizer rotation program and implement improved procedures and a master sanitation schedule to include all facility areas; and develop a company-wide food safety culture through training.
However, your response does not provide sufficient details for FDA to evaluate the adequacy of your corrective actions, such as the methods and specific activities you will utilize to achieve compliance for each corrective action. For example:
- Your response does not include a detailed description of your changes to product handling and movement and restricting access to production areas. You stated that access to the process area has been restricted, but you did not provide further details about what restrictions you have implemented. With respect to product handling and movement, you stated that you plan to segregate raw, repackaged, work-in-progress, and RTE product from one another; but you did not provide a diagram or other detailed information about how employees and product will move during processing to ensure that this and any other necessary safety controls will be achieved. Adequate food safety controls, operating practices, and facility design can reduce the potential for contamination by using location and/or flow of humans, product, equipment, and air. For more information about ways to minimize microbial hazards in your facility, you can refer to FDA’s Guidance for Industry: GUIDE TO MINIMIZE MICROBIAL FOOD SAFETY HAZARDS OF FRESH-CUT FRUITS AND VEGETABLES, which is available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/ucm064458.htm.
- You state that you will clean and sanitize all equipment daily and develop a sanitizer rotation program, but you did not provide specifics of these changes, including how the equipment will be cleaned and sanitized and what sanitizers will be used. Some food processing equipment such as your (b)(4) may need to be taken apart to perform adequate cleaning and sanitizing to prevent microbial harborage and contamination.
- Your response indicates that you plan to alter your environmental monitoring program to be more proactive in uncovering areas of microbial harborage. Please clarify how your environmental monitoring program has been revised, including any environmental testing for pathogens. Your response does not describe when monitoring of the environment will take place (e.g., after at least 3 hours of active food production rather than immediately after cleaning/sanitation operation) and the number and locations of samples or swabs to be taken. FDA recommends that you collect swabs from food contact surfaces during production at least weekly to allow you to take corrective action before Listeria colonizes your equipment and facility, and at a time that is both prior to cleanup and no sooner than the middle of production. In Section XVI of FDA’s draft guidance entitled Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance, we recommend measures to monitor critical surfaces and areas to detect locations that harbor Listeria species or L. monocytogenes. Our draft guidance is available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodProcessingHACCP/ucm073110.htm.
Furthermore, your response did not include corrective actions your firm will take when microbial contamination is found. In the Draft Guidance previously mentioned, FDA also recommends that you have a written environmental monitoring plan for Listeria that includes corrective actions you will take upon finding samples that are positive.
The above violations are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products are in compliance with the Act and all applicable regulations, including the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110].
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action by FDA without further notice. Further actions could include, but are not limited to, seizure and/or injunction.
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. A re-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)). For a domestic facility, 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.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. We also request that you contact this office within fifteen (15) working days to arrange a meeting to discuss your sanitation standard operating procedures (SSOPs), revisions to your Listeria control plan, and our ongoing concerns.
Please send your written reply to this letter to the U.S. Food and Drug Administration, Attention: Mark E. Parmon, Compliance Officer, at the address above. To arrange the meeting please contact Compliance Officer Parmon at (513) 679-2700, Ext. 2162, or via email at firstname.lastname@example.org.
Paul J. Teitell