Inspections, Compliance, Enforcement, and Criminal Investigations
LushLife Gardens 1/18/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
January 18, 2012
VIA UPS OVERNIGHT
Mr. Daniel Paolicelli
202 Mount Nebo Rd
Milford, NJ 08848
File No.: 12-NWJ-06
Dear Mr. Paolicelli:
The Food and Drug Administration (FDA) conducted an inspection of your sprout processing facility, located at 202 Mount Nebo Road, Milford, NJ, from November 15-21, 2011. We conducted this inspection in response to a sample of your "Saladini" brand alfalfa sprouts, collected and analyzed by New York State Department of Agriculture and Markets (NYAG) under a cooperative program with the United States Department of Agriculture's (USDA) Microbiological Data Program, that yielded Listeria monocytogenes (L monocytogenes). During the inspection, our investigators documented observations of insanitary conditions and an analysis of environmental swabs collected during the inspection found the pathogen Listeria monocytogenes (L monocytogenes) at two locations in your facility. The conditions observed during the inspection and the finding of L. monocytogenes in your facility cause the sprouts processed 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 U.S. C.§ 342(a)(4)], in that your sprouts have been prepared, packed, or held under unsanitary 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 its associated 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. Immune-compromised individuals and unborn fetuses are particularly susceptible to listeriosis. There was a 50% mortality rate associated with a nosocomial outbreak of listeriosis which occurred in 2009 and was linked to fresh produce. Ready-to-eat (RTE) sprouts have been implicated in outbreaks of invasive listeriosis.
During the inspection, the FDA investigators collected sample number 689489 consisting of 40 environmental swabs. Analysis of two swabs (one an the floor just inside the green house entrance and another on the floor underneath row (b)(4) of (b)(4) yielded L. monocytogenes. One of the isolates was indistinguishable from the strain that was isolated by the NYAG as analyzed with pulse gel electrophoresis (PFGE). We have attached a copy of the analysis which demonstrates that the isolates match for two different kinds of PFGE tests. These observations suggest that the L. monocylogenes isolated from your product by NYAG likely came from the facility.
Our investigators also observed condensate dripping onto seed and sprouts from black fabric, rope and string. The black fabric was not adequately cleaned and sanitized as evidenced by apparent mold growing on the fabric. These conditions are reasonably likely to result in contamination of your product with L. monocylogenes.
We acknowledge your response sent January 2, 2012; however, it is inadequate because it does not provide documentation of the corrective actions you describe.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of the Act and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
It may be helpful to consult FDA's guidance document, Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, which includes information on recommended seed treatment methods, including means of ensuring seed contact lime with appropriate sanitizers and is available at: http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm. You may also find it useful to watch the training videos jointly developed by the California Department of Public Health and the FDA to assist the industry in producing safer sprouts.
These videos are available at:http://postharvest.ucdavis.edu/Pubs/videolibrary.shtmi#Sprouts. Finally, FDA has published "Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance" to provide guidance on how to control L. monocytogenes in ready to eat foods.
Please notify this office in writing within fifteen (15) working days of receipt of this letter the specific steps that you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3'' Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.
New Jersey District