Is Naturecom Inc. Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 20, 2017
Executive Summary
The FDA issued a warning letter to Naturecom Inc. on April 20, 2017 citing regulatory violations. The letter was issued by Los Angeles District Office.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Naturecom Inc.'s operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Naturecom Inc..
Regulatory Context
The statement of actual yield and statement of the percentage of theoretical yield must be included at appropriate phases of processing in accordance with CFR 111.260(f);
The actual results obtained during the monitoring operations described in steps3 through 6 of the document you provided, in accordance with 21 CFR 111.260(g);
The results of any tests or examinations conducted on packaged and labeled dietary supplements, such as those described in steps 6.1, 6.3, 7, and 8 of the document you provided, in accordance with 21 CFR 111.260(k)(3);
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Naturecom Inc.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Naturecom Inc. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
- What should I do if I've used Naturecom Inc. products?
- If you have used products from Naturecom Inc. 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