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Notice: Official Public Record

Whitestone Feeds LLC FDA Warning (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 14, 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 Whitestone Feeds LLC on July 14, 2017 citing adulteration, cgmp violations. The letter was issued by Cincinnati District Office.

Adulteration CGMP Violations

Detailed Analysis

False Claims and Regulatory Violations

When animal food has become adulterated, management of the establishment must ensure that it is rejected, disposed of, or if appropriate it is treated or processed to eliminate the adulteration. Disposal must be done in a way that protects against the contamination of other animal food (21 CFR 507.25(a)(7)).

Potential Health Risks

Consumers should be aware of potential risks associated with products from Whitestone Feeds LLC.

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 part 507] (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)).

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

Key Entities Identified

21 CFR part 507 21 CFR 507.25 21 CFR 507.25

Frequently Asked Questions

What did the FDA find wrong with Whitestone Feeds LLC?
The FDA issued a warning letter citing adulteration, cgmp violations related to their products or manufacturing practices.
Are Whitestone Feeds LLC products safe to use?
Based on the FDA's findings, consumers should exercise caution. The company was found to have adulteration that may affect product safety.
What should I do if I've used Whitestone Feeds LLC products?
If you have used products from Whitestone Feeds LLC 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.