Wednesday 24 January 2018

FDA Sends Warning Letter to Mushroom, Herb Wholesaler

Oregon news sources are reporting the FDA ordered a wholesaler of gourmet mushrooms and herbs to clean up unsanitary conditions discovered at its facility in Portland.

The FDA issued a warning letter to Farm and Wild Fresh Paradise Gourmet Foods on Aug. 10, citing “serious violations” of good manufacturing processes that could pose a health risk. The warning follows an inspection on April 13, 15 and 20 of the company’s facility.  The FDA said items were “prepared, packed or held under insanitary conditions” that could cause illness. The letter cites a lack of running water for cleaning equipment, a lack of hand-washing facilities at work stations, a lack of protection against contamination, an absence of soap in cleaning and the use of newspapers to cover food. The FDA gave the owner, Hugo F. Chang, 15 days to show he was rectifying the problems.

Facility inspections by the FDA are mandatory. Once a FDA agent arrives on-site they must be allowed access to the facility. A Warning Letter is the last step before the FDA can go to court to enforce regulations. After the FDA agent inspects a facility it will issue a Form 483 that details the findings of the inspections and provides an opportunity to respond and correct. This is often where facility managers and owners get into trouble. It’s important to promptly and thoroughly respond to the Form 483 in order to avoid a Warning Letter. When unsure about how to respond, seek legal counsel. Hiring an attorney at this stage often saves money!

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