What did the FDA find wrong with American Specialty Pharmacy?

The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.

Are American Specialty 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 American Specialty Pharmacy products?

If you have used products from American Specialty Pharmacy and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

American Specialty Pharmacy FDA Warning (2017)

Name: American Specialty Pharmacy FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:20.360072

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on July 28, 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 American Specialty Pharmacy on July 28, 2017 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

If you decide to resume compounding operations in the future, please provide an explanation of each step taken to prevent the recurrence of the violations cited in the warning letter, as well as copies of related documentation. In addition to taking appropriate corrective actions, your firm should notify this office prior to resuming production of any drug products in the future.

Potential Health Risks

Office of Pharmaceutical Quality Operations, Division II4040 N. Central Expressway, Suite 300Dallas, Texas 75204

Abdul Hameed, OwnerAmerican Specialty Pharmacy, Inc.13988 Diplomat Drive, Suite 100Farmers Branch, Texas 75234

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your response to our warning letter (WL# 2016-DAL-WL-27) dated June 28, 2016. From June 13, 2017, to June 14, 2017, FDA investigators conducted an inspection of your facility, American Specialty Pharmacy, located at 2743 W. 15th Street, Plano, Texas 75075-7525. We acknowledge that your firm has ceased production of drugs at this facility.

Regulatory Context

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

American Specialty Pharmacy FDA Warning Letter

Frequently Asked Questions

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