FDA WARNING_LETTER - Hanover Foods Corporation - May 27, 2010

An FDA inspection of Hanover Foods Corporation's produce manufacturing facility in Hanover, Maryland, conducted from April 2009 to May 2010, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Laboratory analysis confirmed the presence of *Listeria monocytogenes* in an in-line sliced mushroom sample and on food contact surfaces, indicating a high risk of finished product contamination. Consequently, foods manufactured at the facility are deemed adulterated under 21 U.S.C. 342(a)(4) due to insanitary conditions. Significant deviations included failure to protect finished food from contamination by refuse and during conveyance (21 CFR 110.80(b)(6)), failure to protect against extraneous material (21 CFR 110.80(b)(8)), improper facility construction allowing drip/condensate contamination (21 CFR 110.20(b)(4)), and inadequate pest protection (21 CFR 110.20(b)(7)). The firm's June 2010 response to the FDA-483 was deemed insufficient. Hanover Foods is required to submit documentation of completed corrective actions, including revised SSOPs and structural modifications, and steps taken to prevent *L. mono* contamination, within 15 working days. Failure to promptly correct these violations may result in regulatory actions such as seizure or injunction.