FDA WARNING_LETTER - MSI Express, Inc. - January 11, 2012

On March 22, 2012, the FDA issued a Warning Letter to J.M. Smucker, LLC following an inspection of their Ripon, Wisconsin facility from January 5-11, 2012. The inspection verified the firm manufactures and distributes acidified food products, specifically Pumpkin Butter.

The letter cited significant violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), rendering their Pumpkin Butter adulterated under 21 U.S.C. § 342(a)(4).

Key violations included: 1. Failure to process Pumpkin Butter in conformity with the filed scheduled process (SID (b)(4)), specifically not ensuring a (b)(4) after filling, as required by 21 CFR 108.25(c)(3)(i). The firm's response was deemed inadequate as it lacked evidence supporting equivalence to the filed process. 2. Failure to maintain records of actions taken to rectify departures from the scheduled process and product disposition for two pumpkin butter lots that failed to meet (b)(4) during filling, violating 21 CFR 114.100(c). The firm's commitment to future record-keeping was noted as an adequate correction for future deviations. 3. Failure to provide requested process source documentation (e.g., process authority letter, heat