Hartley Medical Center Pharmacy, Incorporated FDA Warning (2
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 26, 2017
Executive Summary
The FDA issued a warning letter to Hartley Medical Center Pharmacy, Incorporated on September 26, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Hartley Medical Center Pharmacy, Incorporated's operations or product claims.
Potential Health Risks
Division of Pharmaceutical Quality Operations IV19701 Fairchild RoadLos Angeles, California 92612Telephone:(949) 608-2900Fax:(949) 608-4415
William Stuart, Owner/PresidentHartley Medical Center Pharmacy, Inc.113 W. Victoria StreetLong Beach, CA 90805-2162
Acting for 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 #29-16] dated April 21, 2016. 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.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Hartley Medical Center Pharmacy, Incorporated?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Hartley Medical Center Pharmacy, Incorporated 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 Hartley Medical Center Pharmacy, Incorporated products?
- If you have used products from Hartley Medical Center Pharmacy, Incorporated 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