Hard-E Foods Inc – FDA Warning Letter, May 7, 2010

On May 4-7, 2010, the FDA inspected Hard-E Foods, Inc. in St. Louis, Missouri, a manufacturer of acidified food products, including various pickled eggs. The inspection revealed deviations from the Federal Food, Drug and Cosmetic Act and regulations in 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), rendering the products adulterated under Section 402(a)(4) of the Act due to insanitary conditions.

Significant violations included: 1. Failure to file scheduled processes for any pickled egg products (Pickled Eggs, Garlic Mustard Pickled Eggs, Beet Pickled Eggs, Sweet Pickled Eggs, Hot Pickled Eggs) as required by 21 CFR 108.25(c)(2). 2. Failure to register as a commercial processor of acidified foods with the FDA, despite processing for five years, violating 21 CFR 108.25(c)(1). 3. Failure to establish scheduled processes by a qualified expert in acidification and processing of acidified foods, as required by 21 CFR 114.83. 4. Failure to monitor and record finished equilibrium pH values to ensure they are not higher than 4.6, violating 21 CFR 114.80(a)(2). 5. Failure to properly hold ingredients