FDA WARNING_LETTER - Ipsi Specialty Foods, Inc. - July 11, 2014

On August 26, 2014, the FDA issued a Warning Letter to IPSI Specialty Foods, Inc. following an inspection on July 10-11, 2014, at their La Vista, Nebraska facility, which manufactures pickled chicken eggs. The inspection revealed significant deviations from federal regulations for acidified foods (21 CFR 108 and 21 CFR 114) and current good manufacturing practices (21 CFR Part 110).

Key violations include: 1. **Failure to Register:** The firm has been processing acidified foods for up to 35 years but has not registered with the FDA as a commercial processor of acidified foods (21 CFR 108.25(c)(1)). 2. **Failure to File Scheduled Processes:** No scheduled processes for IPSI Fresh Packed Pickled Eggs have been filed with the FDA (21 CFR 108.25(c)(2)). 3. **Lack of Established Scheduled Processes:** The firm lacks scheduled processes established by a qualified person (21 CFR 114.83). 4. **Inadequate pH Monitoring:** The firm does not monitor or record the finished equilibrium pH of acidified products to ensure it does not exceed 4.6 (21 CFR 114.80(a)(2)). 5. **Facility Maintenance:** Observed rust and peeling paint