FDA WARNING_LETTER - Harold Brey & Sons Inc. - May 29, 2019

The FDA issued a Warning Letter to Mr. & Ms. Brey following an inspection of their shell egg farm and processing plant in Jeffersonville, NY, from May 21-29, 2019. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (21 CFR Part 118). These violations render their shell eggs adulterated under Section 402(a)(4) of the FD&C Act due to insanitary conditions. The FDA evaluated the firm's June 5, 2019, response to the FDA 483. Significant deficiencies included the firm's failure to provide records of employee retraining for poultry house swabbing. Additionally, their proposed corrective actions for rodent monitoring were deemed inadequate, as the response did not specify actions for unacceptable rodent activity. The FDA also noted the firm had been operating without a rodent threshold. While the firm outlined plans for environmental testing, the FDA indicated it would verify the adequacy of these actions during a future inspection. The firm must promptly correct all violations and notify the FDA in writing within 15 working days with specific steps, timelines, and documentation. Failure to comply may result in regulatory actions like seizure or injunction.