FDA WARNING_LETTER - Kaltec Food Packaging Inc. - March 01, 2018

On June 8, 2018, the FDA issued a Warning Letter to Kaltec Food Packaging, Inc. following an inspection from February 12 to March 1, 2018. The inspection revealed serious violations of regulations for acidified foods (21 CFR Part 108 and Part 114), rendering their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to file scheduled processes:** Kaltec did not provide the FDA with scheduled process information for numerous acidified food products, including Jersey Tomato Sauce Marinara, Sweet and Savory Black Bean Sauce, and others, as required by 21 CFR 108.25(c)(2). The firm also lacked evidence that the process for Jersey Tomato Sauce Marinara was established by a qualified person (21 CFR 114.83). 2. **Failure to manufacture in accordance with scheduled process:** * For Sweet and Savory Black Bean Sauce, the firm used different ingredients and failed to maintain the specified fill temperature of (b)(4)°F, with numerous batch records showing temperatures below this critical limit. The firm also failed to reprocess or evaluate deviated product (21 CFR 114.80(a)(1), 21 CFR 114.89).