FDA WARNING_LETTER - Haldiram Snacks Pvt. Ltd. - April 19, 2017

On July 6, 2017, the FDA issued a Warning Letter to Haldiram Snacks Pvt. Ltd. and Haldiram Foods International Pvt. Ltd. following an inspection of their low acid canned food (LACF) facility in Noida, India, on April 18-19, 2017. The inspection revealed serious violations of the Emergency Permit Control regulation (21 CFR 108) and the Low Acid Canned Foods (LACF) regulation (21 CFR 113), rendering their LACF products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. Failure to measure and record a critical factor (viscosity) at sufficient frequency for "Dal Makhni" product, as required by 21 CFR 113.40(j). Monitoring records lacked critical factor for time and temperature. 2. Failure to process LACF in conformity with the scheduled process, as required by 21 CFR 108.35(c)(3)(i). Specifically, "Dal Makhni" viscosity and initial product temperature were below filed process limits, and "Rajma Raseela" initial product temperature was also below the filed process. 3. Failure to identify deviations from the scheduled process or critical factors out of control, and failure to take corrective actions, as required