Americare Compounding, LLC. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 06, 2017
Executive Summary
The FDA issued a warning letter to Americare Compounding, LLC. on February 06, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Americare Compounding, LLC.'s operations or product claims.
Potential Health Risks
Thomas D'Angelo, Co-Owner/PharmacistAmericare Compounding, LLC319 Nassau BlvdGarden City South, NY 11530-5313
Regulatory Context
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our warning letter (NYK-2014-29, April 22, 2014). 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 Americare Compounding, LLC.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Americare Compounding, 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 Americare Compounding, LLC. products?
- If you have used products from Americare Compounding, 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