FDA WARNING_LETTER - Farm and Wild Fresh Paradise Gourmet Foods - April 20, 2011

The FDA conducted an inspection of a produce repacking operation in Portland, Oregon, on April 13, 15, and 20, 2011, documenting serious violations of the Current Good Manufacturing Practice (CGMP) regulation (21 CFR part 110). These deficiencies render the food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. Key violations include the absence of running water for cleaning and handwashing, inadequate employee hygienic practices such as failing to wash hands after contamination and handling food with a bandage, and improper cleaning and sanitizing procedures for utensils and processing surfaces. Additionally, the firm failed to protect work-in-process from contamination, used newspapers as non-cleanable food contact surfaces, and maintained poor storage practices creating pest harborage areas. The firm is required to take prompt corrective action and notify the FDA in writing within fifteen working days, detailing steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction.