Mr. Mark T. Smucker
CEO/Chairman
J.M. Smucker LLC
1 Strawberry Lane
Orville , OH 44667
United States
Mark.Smucker@jmsmucker.comFEI 1021607Issued Jan 24, 2023Division of Human and Animal Food Operations East V
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1021607.
Violations2
Issue DateJan 24, 2023
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
J.M. Smucker LLC
Location
Mr. Mark T. Smucker
CEO/Chairman
J.M. Smucker LLC
1 Strawberry Lane
Orville , OH 44667
United States
Mark.Smucker@jmsmucker.com
FEI Number
1021607
Country
United States
Issue Date
January 24, 2023
Issuing Office
Division of Human and Animal Food Operations East V
Product Type
Food & Beverages
Status
Open
Summary
J.M. Smucker LLC was warned about adulterated ready-to-eat peanut butter manufactured at its Lexington, Kentucky facility that was linked to a multistate Salmonella Senftenberg outbreak affecting 21 people across 17 states. The inspection uncovered serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls requirements under 21 CFR Part 117, with peanut butter prepared, packed, or held under insanitary conditions that may have been contaminated with Salmonella. The FDA and Kentucky health officials determined that the facility's peanut butter was the source of the outbreak, leading the company to recall all product manufactured between October 1, 2021, and May 20, 2022.
J.M. Smucker LLC FDA Warning Letter, January 24, 2023