Category Archives: FDA Warning Letter

FDA

Reference: CMS Case 672629

Dear Mr. Lawson:

The United States Food and Drug Administration (FDA) conducted an inspection of your shell egg farm and egg processing facility, where your eggs are washed and packed, located at 4307 Roland Hayes Parkway SW in Calhoun, Georgia, between October 23, 2023, and October 27, 2023. During our inspection, FDA investigators found serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118), as well as sanitation concerns in your egg processing facility. Additionally, FDA collected environmental samples (i.e., swabs) from your farm and detected the presence of Salmonella Enteritidis (SE) as further described in this letter.

Based on FDA’s inspectional findings, we have determined that the shell eggs produced on your farm do not comply with the provisions of 21 CFR Part 118. Failure to comply with 21 CFR Part 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 United States Code (U.S.C.) § 264(a). In addition, these violations and analytical findings render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the FD&C Act, the PHS Act, and the shell egg regulation though links on FDA’s homepage at http://www.fda.gov.

At the conclusion of the inspection, FDA investigators issued you a Form FDA 483 (FDA-483), Inspectional Observations. You provided written responses to the inspectional findings dated November 10, 2023, December 4, 2023, December 12, 2023, and multiple updates throughout January 2024 describing additional corrective actions. We are issuing this letter to advise you of FDA‘s continued concerns based on the inspectional findings, sample and analytical results, and our review of your responses.

FDA

On June 28-29, 2023, the Iowa Department of Agriculture, under contract with the Food and Drug Administration (FDA), inspected your shell egg farm and egg processing facility, where your eggs are washed, graded, and packed, located at 3407 Kirkwood Ave., Osage, IA 50461. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the Shell Egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118). Failure to comply with the provisions of 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, the PHS Act and Shell Egg regulation through links on FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection, Iowa Department of Agriculture State inspectors issued Mr. Jose Hernandez, Site Manager, an FDA Form 483 (FDA-483), Inspectional Observations. To date, FDA has not received a response describing corrective actions. Based on our review of the inspectional findings, we are issuing this letter to advise you of our concerns and to provide detailed information describing the findings at your farm. Your significant violations are as follows:

1.  You did not have and implement a written Salmonella Enteritidis (SE) Prevention Plan that includes, at minimum, the SE prevention measures required by 21 CFR118.4. You have a document titled “SE Prevention Plan”; however, as describedbelow, this plan is inadequate in that it does not address all required SE prevention measures.