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Is Texas Plum Line Safe? FDA Warning Letter Review (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 22, 2017

CRITICAL SEVERITY Dallas 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 Texas Plum Line on September 22, 2017 citing hidden ingredients. Consumers who have purchased products from this company should exercise caution. The letter was issued by Dallas District Office.

Hidden Ingredients

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Texas Plum Line's operations or product claims.

Potential Health Risks

Your firm failed to prepare and maintain current procedures for products under your control that you will ask your distributors to follow, including plans for effecting recalls of any products that may be injurious to health; for identifying, collecting, warehousing, and controlling the product; for determining the effectiveness of such recall; for notifying the FDA of any such recall; and for implementing such recall program, as required by 21 CFR 108.35. Specifically your firm’s recall procedures are inadequate due to not maintaining the required elements as required by 21 CFR 108.35. During the previous inspection, your firm voluntarily initiated a recall due to undeclared milk and wheat in your finished product without having a proper recall procedure.

Regulatory Context

This warning letter is part of the FDA's enforcement of federal regulations.

Key Entities Identified

21 CFR 108.35 21 CFR 108.35

Frequently Asked Questions

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