FDA WARNING_LETTER - Lushlife Gardens - November 21, 2011

The FDA conducted an inspection of Lushlife Gardens' sprout processing facility in Milford, NJ, from November 15-21, 2011, following a New York State Department of Agriculture and Markets (NYAG) sample of "Saladini" brand alfalfa sprouts that tested positive for *Listeria monocytogenes* (*L. monocytogenes*).

During the inspection, FDA investigators documented insanitary conditions and found *L. monocytogenes* in two environmental swabs from the facility floor. One isolate was indistinguishable from the strain found by NYAG, suggesting the product contamination originated from the facility. Investigators also observed condensate dripping onto seeds and sprouts from unclean black fabric, rope, and string, with apparent mold growth on the fabric, which could lead to product contamination.

These conditions render the sprouts adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)], as they were prepared, packed, or held under unsanitary conditions. The FDA acknowledged the firm's January 2, 2012, response but deemed it inadequate due to a lack of documentation for described corrective actions.

Lushlife Gardens is required to take prompt action to correct these violations and prevent recurrence. Failure to do so may result in legal action, including seizure and injunction. The firm must notify the FDA in writing within fifteen