What did the FDA find wrong with Wellington Foods?

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

Are Wellington Foods products safe to use?

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

What should I do if I've used Wellington Foods products?

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

Is Wellington Foods Safe? FDA Warning Letter Review (2017)

Name: Is Wellington Foods Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:16.162115

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 06, 2017

MODERATE SEVERITY Los Angeles 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 Wellington Foods on January 06, 2017 citing labeling violations. The letter was issued by Los Angeles District Office.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

Your internal specifications for purified water used as a component in your finished dietary supplement products includes(b)(4)to be absent per 100ml. Your firm appeared to start testing for the presence of(b)(4)in your purified water in July 2015. A review of yourMicrobial Evaluation of Waterrecords from July, 2015 through April 28, 2016 found 37 instances where(b)(4)was present in your treated water sampling points(b)(4), yet this component was not rejected.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Wellington Foods.

Regulatory Context

Sodium copper chlorophyllin, to which you assigned lot number(b)(4), was found by in-house analysis on November 6, 2014 to have a total copper content of(b)(4)%. Confirmative analysis by an outside laboratory found total copper content to be(b)(4)%. Your specification for sodium copper chlorophyllin references total copper content to be not less than(b)(4)% and not more than(b)(4)%. The dietary ingredient was approved by your quality control personnel on November 11, 2014 without justification for the out-of-specification material and used in the manufacture of Product WF250680, liquid multivitamin supplement, lot 358-1-A5 on January 6, 2015 and lot 330-2-B5 on February 3, 2015.

Your firm’s quality control personnel failed to conduct a material review and make a disposition decision when an established specification under 21 CFR 111.70(b)(3) was not met [21 CFR 111.113(a)(1)]. For example,

Key Entities Identified

21 CFR 111.70 21 CFR 111.113

Frequently Asked Questions

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