FDA WARNING_LETTER - Ed Fields & Sons, Inc - February 11, 2014

On February 3-5 and 11, 2014, the FDA inspected Ed Fields & Sons, Inc.'s vegetable farm due to analytical findings of Linuron in their parsnips exceeding the established tolerance. The Environmental Protection Agency (EPA) sets these tolerances in 40 CFR 180.184.

The parsnips were found to be adulterated under section 402(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(2)(B)), as they contained Linuron at unsafe levels, exceeding the 0.05 ppm tolerance. Specifically, samples analyzed on November 21, 2013, showed Linuron at 0.191 ppm and 0.265 ppm (original and check analysis), while samples from January 3, 2014, contained 0.098 ppm and 0.114 ppm.

The company is required to take prompt action to correct this violation. Failure to do so may result in regulatory actions such as seizure or injunction. A written response outlining specific corrective steps and a plan to prevent recurrence is required within 15 working days of receiving the letter. If corrections cannot be completed within this timeframe, an explanation for the delay and a timeline for completion must be provided.