NewsMedium impact

FDA warning letter to Dreyer's ice cream cone plant cites years of environmental Listeria findings

Source date Published

Key facts

Type / category
News / Warning letter
Agency
FDA
Source date
Sectors
Food
Standards
  • 21 CFR 117
Reference
MARCS-CMS 727644

On October 13, 2026, FDA posted a September 29, 2026 warning letter to Dreyer's Grand Ice Cream, Inc. for its plant in Bakersfield, California, which makes frozen ready-to-eat ice cream cone products. FDA inspected the plant from January 27 to February 20, 2026 and found serious violations of the CGMP and preventive controls rule, 21 CFR Part 117. The investigator's review of environmental monitoring records from 2021 through February 5, 2026 showed ongoing Listeria monocytogenes and Listeria spp. findings throughout production and auxiliary areas, including 19 Listeria positives and 8 confirmed L. monocytogenes positives in 2026 as of February 5. Even so, according to FDA, the plant's hazard analysis concluded that pathogen contamination was not a significant hazard because a sanitation prerequisite program controlled it, and the firm did not document root cause investigations and corrective actions for certain zone findings, contrary to its own procedure.

The investigator also saw employees move between trash, cardboard and other non-food-contact surfaces and food-contact surfaces or ready-to-eat ingredients without changing gloves or washing or sanitizing their hands, and hygienic barriers at doorways that were not being used or maintained. FDA acknowledged the firm's corrective actions, including a new pathogen investigation form, but said they did not address why earlier actions failed to prevent Listeria from recurring, whether a facility-wide deep clean was done, or how the sampling plan and schedule were developed. FDA also noted that the glove swabs the firm used to verify hand hygiene measure Enterobacteriaceae, which does not detect Listeria spp. FDA says it will verify the corrections during a follow-up inspection.

What it means for labs

If your lab runs environmental monitoring for ready-to-eat food plants, this letter shows that FDA expects repeat Listeria positives to drive the hazard analysis, root cause work and a documented rationale for the sampling plan. It is also a reminder that an indicator test verifies only what it measures, since Enterobacteriaceae glove swabs do not show whether Listeria is under control.

Sources

This summary is for general information and may not reflect later changes. Always check the official source linked above. It isn't legal or regulatory advice, and Micro-Core Consulting isn't affiliated with the agencies or standards bodies named.