FDA WARNING_LETTER - G. Wolf Enterprises, Inc. - May 14, 2014

The FDA conducted inspections of Mr. Wolf's food processing facility in Gold Bar, Washington, from September 2013 to May 2014, revealing serious deviations from regulations for acidified foods (21 CFR Part 108 and 114), Seafood HACCP (21 CFR Part 123), and Current Good Manufacturing Practice (21 CFR Part 110). These deficiencies render the firm's acidified food and seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to file scheduled processes for seventeen acidified food products, inadequate examination of jars to prevent leakage, and manufacturing acidified foods not in accordance with the scheduled process. The firm also failed to record process deviation evaluations and lacked a HACCP plan for a shrimp-containing spice condiment to control undeclared allergens. Sanitation issues observed included mold/dust on piping, containers on wet floors, use of non-cleanable materials, pooled liquids, and residue in a steam cooker. The firm's responses were deemed inadequate, lacking documentation for corrective actions. The FDA requires a written response within fifteen working days outlining specific corrections and providing supporting documentation. Failure to comply may lead to further enforcement actions, including product seizure, injunctions, and re-inspection fees.