The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) ice cream product manufacturing facility, located at 2 Church Avenue, Brooklyn, NY 11218-3096, from February 21 through March 26, 2024. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
Based on FDA’s inspectional findings and analytical results revealing L. monocytogenes in your production environment, we have determined that the RTE ice cream products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive control provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at https://www.fda.gov.
Multistate Listeria monocytogenes Outbreak Linked to Ice Cream House
In July 2023, FDA, the Centers for Disease Control and Prevention (CDC), the New York State Department of Agriculture and Markets (NYSDAM), and the Pennsylvania Department of Agriculture (PDA) investigated a multistate outbreak of L. monocytogenes linked to ice cream products manufactured by your firm. The outbreak was associated with 2 cases in 2 states (New York and Pennsylvania) where both individuals were hospitalized and ultimately survived. Whole Genome Sequencing (WGS) performed on the clinical isolates from the cases in New York and Pennsylvania revealed that the clinical isolates matched the finished product samples that PDA collected from a private residence on July 27, 2023, and NYSDAM collected from your facility on August 4, 2023, and August 21, 2023. On August 30, 2023, your firm recalled all dairy and non-dairy ice cream products manufactured with the Ice Cream House logo. In response to this outbreak and the findings from an initial inspection of your firm conducted on September 6, 2023, through September 26, 2023, FDA conducted the current follow-up inspection. At the conclusion of the current inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. We received your written response to the sample findings and FDA-483 on April 16, 2024, describing corrective actions taken by your firm. We are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We discuss your written response below.
FoodWorld 