Avella of Deer Valley, Inc. dba Avella FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 03, 2017
Executive Summary
The FDA issued a warning letter to Avella of Deer Valley, Inc. dba Avella on February 03, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Avella of Deer Valley, Inc. dba Avella's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Avella of Deer Valley, Inc. dba Avella.
Regulatory Context
The Food and Drug Administration has completed an evaluation of Avella’s corrective actions in response to our warning letter (WL# 10-14, January 17, 2014) issued based on our inspectional findings at your facility located at 23620 N. 20th Drive, Suite 12, Phoenix, AZ 85085. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Avella of Deer Valley, Inc. dba Avella?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Avella of Deer Valley, Inc. dba Avella 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 Avella of Deer Valley, Inc. dba Avella products?
- If you have used products from Avella of Deer Valley, Inc. dba Avella 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