SaveWay Compounding Pharmacy, Inc. FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 28, 2018
Executive Summary
The FDA issued a warning letter to SaveWay Compounding Pharmacy, Inc. on March 28, 2018 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in SaveWay Compounding Pharmacy, Inc.'s operations or product claims.
Potential Health Risks
Brenda L. Poland Vice PresidentSaveWay Compounding Pharmacy, Inc.31 Albe Drive, Suite 1Newark, DE 19702-1360
Yvette Johnson, Compliance OfficerOffice of Pharmaceutical Quality Operations, Division IPhiladelphia District Office
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 #17-PHI-01) dated October 4, 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 SaveWay Compounding Pharmacy, Inc.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are SaveWay Compounding Pharmacy, Inc. 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 SaveWay Compounding Pharmacy, Inc. products?
- If you have used products from SaveWay Compounding Pharmacy, Inc. 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