FDA WARNING_LETTER - Kandagis Inc. d.b.a. Gourmet Factory - April 30, 2015

An FDA inspection of Kangadis Inc. d.b.a. Gourmet Factory, located in Hauppauge, NY, was conducted from April 15-30, 2015, revealing serious violations of regulations for acidified foods (21 CFR Part 108 and Part 114). The FDA determined the firm's acidified food products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to preparation, packing, or holding under insanitary conditions.

Key violations include: 1. Failure to provide scheduled processes to the FDA for acidified food products, such as chopped garlic in oil and water (128oz and 32oz jars), as required by 21 CFR 108.25(c)(2). Previous submissions in 2013 were rejected for lacking sufficient thermal heat treatment or challenge studies to achieve a 5-log reduction of vegetative cells (21 CFR 114.80(a)(1)). The firm's May 15, 2015, response acknowledged this but lacked updated submissions. 2. Failure to establish scheduled processes by a qualified person with expert knowledge in acidified food processing, as required by 21 CFR 114.83. The processes for the garlic products were not established by a competent authority. The firm's response indicated