FDA WARNING_LETTER - River Valley Ranch Ltd - May 02, 2011

An FDA inspection of River Valley Ranch Ltd. in Burlington, Wisconsin, conducted in April and May 2011, revealed significant violations concerning the manufacturing and distribution of acidified food products. The firm failed to comply with federal regulations outlined in 21 CFR 108 and 21 CFR 114. Key deficiencies included the failure to provide the FDA with scheduled processes for new acidified products, such as various salsas and dips, prior to packing (21 CFR 108.25(c)(2)). Additionally, the firm did not adequately examine containers to ensure protection from leakage and contamination (21 CFR 114.80(a)(4)), failed to maintain records identifying the initial distribution of finished products (21 CFR 114.100(d)), and lacked sufficient control and recording of results to ensure finished equilibrium pH values were not higher than 4.6 (21 CFR 114.80(a)(2)). These failures render the firm's acidified products adulterated under section 402(a)(4) of the Act. The FDA acknowledged the firm's response to the Form FDA-483. River Valley Ranch Ltd. is required to submit a written response within 15 working days detailing corrective actions and preventive measures, with supporting documentation. Failure to promptly address these violations may result in enforcement actions, including seizure, injunction, or emergency permit actions.