Wild Thymes Farm Inc., which sells its products by mail and through popular retailers, has run afoul of the U.S. Food and Drug Administration’s (FDA’s) acidified food regulations.
FDA says Wild Thymes’ acidified Indonesian Peanut Sesame Dipping Sauce has been packed or held under insanitary conditions whereby it may have been rendered injurious to health.
The Greenville, NY-based manufacturing facility also has misbranded its peanut sesame dipping sauces and its mango papaya chutney products, according to FDA.
In a Dec. 20 warning letter to Wild Thymes, FDA said there are significant violations in the acidified food manufacturing processes being used by Wild Thymes. It found Wild Thymes is not processing each food in conformity with a schedule, including:
-Temperatures are not recorded or the fill temperature is below the desired temperature.
-The kettle/cook temperature records do not indicate if the desired temperature was reached.
-No cold spot determination was made for batches made between Aug. 14, 2007 and June 3, 2010.
-Numerous process changes were made that were never reported to FDA as required.
“Containers either must be inverted after filling or be subjected to any acceptable method for applying heat to the lid in order to kill any residual pathogens,” the warning letter says. FDA said its investigator “observed containers being hand tightened without any inversion.”
Scheduled process information for acidified or low acid canned food must be submitted to FDA on its Form 2541a.
FDA said Wild Thymes should be doing frequent testing and recording at the batch level. It recommends checks at the start, middle and end of each batch. The agency also recommends instruments and controls for monitoring or recording temperatures and pH level to control the growth of undesirable microorganisms.
The warning letter cited numbers dates when data went unrecorded and batches were nevertheless allowed to enter the food supply. This has included instances was no additional examination or testing done.
None of Wild Thymes personnel have completed FDA approved Better Process Control School, and did not keep deviation logbooks, and did not put proper Identifying codes on the product so it could be traced back.
Wild Thymes labels were misbranding its products in numerous ways, from not listing ingredients properly to quantitative amounts of nutrients being figured wrong.
FDA wanted Wild Thymes documented response within 15 workings days to be submitted to its Buffalo office.