FDA WARNING_LETTER - Wild Thymes Farm, Inc. - July 23, 2010

On December 20, 2010, the FDA issued a Warning Letter to Wild Thymes Farm Inc. following an inspection from July 7-23, 2010. The inspection revealed serious deviations from Acidified Food regulations (21 CFR Parts 108 and 114) and food misbranding under Section 403 of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Adulterated Acidified Food:** Failure to process Indonesian Peanut Sesame Dipping Sauce according to the scheduled process, with inconsistent fill temperatures, unverified kettle temperatures, and no cold spot determination. 2. **Unfiled Process Changes:** Significant changes to the Roasted Peanut Sesame Dipping Sauce recipe (e.g., dried vs. fresh ingredients, different oils, water volume changes) and container closure procedures were not submitted to FDA as revised scheduled processes (21 CFR 108.25(c)(2)). 3. **Insufficient pH Testing:** Only one bottle per batch of Indonesian Peanut Sesame Dipping Sauce was tested for finished equilibrium pH, insufficient for batch sizes up to (b)(4) bottles (21 CFR 114.80(a)(2)). 4. **Uncalibrated Instruments:** Thermometers and other instruments used for monitoring critical conditions were not calibrated or adequately maintained, with some two years past due (21 CFR 110