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Nora Apothecary Pharmacy FDA Warning (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 10, 2017

MODERATE SEVERITY 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 Nora Apothecary Pharmacy on August 10, 2017 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Nora Apothecary Pharmacy's operations or product claims.

Potential Health Risks

Division of Pharmaceutical Quality Operations III300 River Place, Suite 5900Detroit, MI 48207Telephone: (313) 393-8100Fax: (313) 393-8139

Anthony S. Kantzavelos, PharmDPresident & OwnerRxCompounding, Inc.1101 E 86th St.Indianapolis, IN 46240-3729

Nicholas LyonsCompliance DirectorDivision of Pharmaceutical Quality Operations III

Regulatory Context

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL 2014-DET-05, February 14, 2014). Based on our evaluation of the documentation you provided, it appears that you have adequately addressed most of 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 FDA’s 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

Nora Apothecary Pharmacy FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Nora Apothecary Pharmacy?
The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Nora Apothecary Pharmacy 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 Nora Apothecary Pharmacy products?
If you have used products from Nora Apothecary Pharmacy 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.