Hyline Orchards – FDA Warning Letter, Apr 30, 2013

The FDA conducted an inspection of Hyline Orchards' acidified food facility in Fish Creek, Wisconsin, on March 26, April 8, and April 30, 2013. The inspection revealed serious violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), 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:** The firm did not provide FDA with scheduled process information for End of Garden Salsa, Vegetarian Soup, pickle relishes, Dill Pickled Eggs, and Jalapeno Peppers Pickles for each container size, as required by 21 CFR 108.25(c)(2). 2. **Failure to manufacture in accordance with scheduled process:** German Style Red Cabbage (lot codes 20201122, 20201181) was processed for a shorter duration than specified in the scheduled process, violating 21 CFR 114.80(a)(1). This deviation was not recorded or evaluated by a competent processing authority (21 CFR 114.89). 3. **Failure to maintain processing and production records:** The firm did not maintain records showing adherence to scheduled processes, including pH measurements and