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Prescription Lab Compounding Pharmacy FDA Warning (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on June 27, 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 Prescription Lab Compounding Pharmacy on June 27, 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 Prescription Lab Compounding Pharmacy's operations or product claims.

Potential Health Risks

David A. Nicoletti, R.Ph., PresidentMFP Limited, dba Prescription Lab Compounding Pharmacy6586 E. Grant RoadTucson, AZ 85715

CDR Steven E. Porter, Jr.Director, Division of Pharmaceutical Quality Operations IV

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#07-17) dated November 16, 2016. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Key Entities Identified

Prescription Lab Compounding Pharmacy FDA Warning Letter

Frequently Asked Questions

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