Whitestone Feeds LLC FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 14, 2017
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.
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
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