USA – Warning Letter – Swan Brothers Dairy Inc

FDA

Delivery Method:
UPS Overnight
Product:
Food & Beverages

Recipient:
Diane Williamson
President/Owner
Swan Brothers Dairy Inc

938 E 5th StreetClaremoreOK 74017United States

Issuing Office:
Office of Human and Animal Food Operations West Division 3

United States


WARNING LETTER
CMS Case # 61934

January 28, 2022

Dear Ms. Williamson:

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) cheese manufacturing facility located at, 938 E 5th Street, Claremore, Oklahoma, from July 26, 2021 through July 30, 2021. In addition to manufacturing RTE cheese products, you also produce unpasteurized and pasteurized milk. Our inspection was initiated after Oklahoma Department of Agriculture, Food and Forestry (ODAFF) was notified of a report from Missouri Department of Health and Senior Services (MDHSS) which documented that an individual was hospitalized with listeriosis after purchasing and consuming raw cow’s milk from your firm. Subsequently, you conducted a voluntary recall of your unpasteurized milk and cheese products.

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). During this inspection, 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 L. monocytogenes, a human pathogen, in your facility. At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.

Based on FDA’s inspectional findings, we have determined that your RTE cheese 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 been contaminated with filth or rendered injurious to health. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.External Link Disclaimer

On August 6, 2021, you submitted a Qualified Facility Attestation for Human Food Facility. Additionally, we received your written responses on August 20, 2021, August 24, 2021, and September 11, 2021, which describe your completed and planned corrective actions. After reviewing the inspectional findings and responses you provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

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