FDA WARNING_LETTER - Amish Wedding Foods Inc - May 12, 2010

The FDA conducted inspections of Amish Wedding Foods, Inc. on April 15, 16, 21, and May 7, 11, 12, 2010, at their Millersburg, Ohio facility, identifying serious deviations from low-acid food regulations for Sweet Potato Butter and Pumpkin Butter. These products were found to be adulterated under Section 402(a)(4) of the Act because they were prepared, packed, or held under insanitary conditions.

Laboratory analysis of Sweet Potato Butter (lot 01061237) showed pH values from 4.69 to 4.88 and water activity from 0.928 to 0.94. Pumpkin Butter (lot 00781239) had pH values from 4.58 to 4.84 and water activity from 0.945 to 0.971. These values exceed the required pH of 4.6 and water activity of 0.85 for low-acid foods, failing to prevent pathogenic microorganism growth as per 21 CFR 110.80(b)(4).

The firm failed to file scheduled processes for their low-acid food products (Pumpkin Butter and Sweet Potato Butter) with the FDA, violating 21 CFR 108.35(c)(2).

Additionally,