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
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.
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
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