Jack P. Herick, Inc. dba Glades Drugs FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 21, 2017
Executive Summary
The FDA issued a warning letter to Jack P. Herick, Inc. dba Glades Drugs on April 21, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Jack P. Herick, Inc. dba Glades Drugs's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Jack P. Herick, Inc. dba Glades Drugs.
Regulatory Context
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to the warning letter (ref: WL# FL-16-22) to your firm on August 9, 2016. We acknowledge that you have implemented new standard operating procedures related to compounding, including compounding from bulk drug substances, and that you have also begun random testing of your compounded products. Based on our evaluation, it appears that you have addressed the violations contained in the 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 Jack P. Herick, Inc. dba Glades Drugs?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Jack P. Herick, Inc. dba Glades Drugs 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 Jack P. Herick, Inc. dba Glades Drugs products?
- If you have used products from Jack P. Herick, Inc. dba Glades Drugs 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