# FDA WARNING_LETTER - Burkmann Industries Inc. - June 27, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/burkmann-industries-inc/4c3b7362-cf99-4022-815d-e6703fe4c249

> FDA WARNING_LETTER for Burkmann Industries Inc. on June 27, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Burkmann Industries Inc.
- Inspection Date: 2017-06-27
- Product Type: Food
- Office Name: Cincinnati District Office
- Summary: On August 29, 2017, the FDA issued a Warning Letter to Burkmann Industries Inc. following an inspection from June 2-27, 2017, at their Danville, KY facility. The inspection was prompted by a Reportable Food Registry (RFR) event on May 30, 2017, concerning the death of at least 23 cattle after consuming the firm's 2858 - WCN Balancer R1400 TZI product, which contained elevated Monensin levels.

The FDA found serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations. Specifically, the firm manufactured and distributed a medicated animal food (2858 - WCN Balancer R1400 TZI, lot 205087-3) with a superpotent concentration of Monensin (9070 grams per ton, 648% of labeled concentration). This rendered the product unsafe under section 512(a)(2)(A)(i) and adulterated under section 501(a)(6) of the FD&C Act.

The inspection also revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for non-licensed medicated animal food manufacturers (21 CFR Part 225), making the product adulterated under Section 501(a

## Related Officers

- [District Director at FDA](https://www.globalkeysolutions.net/people/steven-barber/e766c0f7-0002-400f-b83a-a0a6efbf259c)

Company: https://www.globalkeysolutions.net/companies/burkmann-industries-inc/3191763a-42f9-4831-8f6e-d8bc43b67dc5

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22