Physician Preferred Medical, LLC FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 28, 2017
Executive Summary
The FDA issued a warning letter to Physician Preferred Medical, LLC on July 28, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Physician Preferred Medical, LLC's operations or product claims.
Potential Health Risks
Office of Pharmaceutical Quality Operations, Division II4040 N. Central Expressway, Suite 300Dallas, Texas 75204
Kenneth Ryan Orton, OwnerPhysician Preferred Medical, LLC dba PPM Pharmacy3300 NW 56th Street, Suite 101Oklahoma City, OK 73112
John W. DiehlActing Director, Compliance BranchOffice of Pharmaceutical Quality Operations, Division II
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 (2016-DAL-WL-08) dated January 20, 2016. We acknowledge that your firm no longer produces sterile drug products. 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 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.If you have additional questions, please contact me at 214-253-5288.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Physician Preferred Medical, LLC?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Physician Preferred Medical, LLC 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 Physician Preferred Medical, LLC products?
- If you have used products from Physician Preferred Medical, LLC 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