FDA WARNING_LETTER - Sunshine International Foods, Inc. - February 19, 2019

The FDA inspected a Ready-to-Eat (RTE) tahini manufacturing facility at 26 Spruce Street, Methuen, MA, from January 30 to February 19, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR 117), rendering the RTE tahini products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR 117.130(a)(1), (c)(1)(ii)):** The firm's hazard analyses failed to identify environmental pathogens like *Salmonella* as a known or reasonably foreseeable hazard for RTE tahini products exposed to the environment post-pasteurization or during repackaging. 2. **Lack of Preventive Controls (21 CFR 117.135(a)(1)):** * Food safety plans for RTE Tahini and RTE Flavored Tahini did not identify pasteurization as a process preventive control for pathogenic bacteria like *Salmonella* in raw sesame seeds. * No sanitation control procedures were established for cleaning and sanitizing the portable filler used for RTE flavored tahini, which is exposed to the environment. 3. **Inadequate Corrective Action Procedures (2