FDA WARNING_LETTER - Mabel's Taste of Home, Inc. - October 02, 2007

The FDA conducted an inspection of Mabel's Taste of Home, Inc., an acidified food manufacturing facility, from September 27 to October 2, 2007. The inspection revealed serious deviations from Acidified Food regulations (21 CFR Parts 108 and 114) concerning products like Jalapeño Pickled Quail Eggs, Jalapeño Baby Corn, and Jalapeño Baby Mushrooms, rendering them adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm failed to: 1) register its establishment with FDA within 10 days of engaging in acidified food manufacturing, as required by 21 CFR 108.25(c)(1); 2) provide scheduled process information to FDA within 60 days of registration and before packing new products, per 21 CFR 108.25(c)(2); and 3) ensure scheduled processes were established by a qualified person with expert knowledge, as mandated by 21 CFR 114.83. These deficiencies were previously communicated in a September 2004 letter and remain uncorrected. Mabel's Taste of Home, Inc. is required to notify FDA within 15 working days of receipt of the letter, detailing specific corrective actions taken, including documentation and a timeline for completion. Failure to promptly correct these deviations may lead to further regulatory actions, including product seizure, injunction, or an Order of Need to Obtain and Hold a Temporary Emergency Permit.