What did the FDA find wrong with Burkmann Industries Inc.?

The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.

Are Burkmann Industries Inc. products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.

What should I do if I've used Burkmann Industries Inc. products?

If you have used products from Burkmann Industries Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Burkmann Industries Inc. FDA Warning (2017)

Name: Burkmann Industries Inc. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:21.346417

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 29, 2017

MODERATE SEVERITY Cincinnati District Office 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to Burkmann Industries Inc. on August 29, 2017 citing cgmp violations. The letter was issued by Cincinnati District Office.

CGMP Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Burkmann Industries Inc.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Burkmann Industries Inc..

Regulatory Context

Management of the establishment must ensure that all operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with the current good manufacturing practice requirements of this subpart (21 CFR 507.25(a)(1)).

Management of the establishment must ensure adequate precautions are taken so that plant operations do not contribute to the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials (21 CFR 507.25(a)(5)).

Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling, must be performed in a way that protects against the contamination of animal food(21 CFR 507.25(c)(4)).

Key Entities Identified

21 CFR 507.25 21 CFR 507.25 21 CFR 507.25

Frequently Asked Questions

What did the FDA find wrong with Burkmann Industries Inc.?: The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
Are Burkmann Industries Inc. products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.
What should I do if I've used Burkmann Industries Inc. products?: If you have used products from Burkmann Industries Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.