Is Corin Ltd Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 09, 2017
Executive Summary
The FDA issued a warning letter to Corin Ltd on February 09, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Corin Ltd's operations or product claims.
Potential Health Risks
Department of Health and Human Services
Matthew Krueger, M.S.E.Acting DirectorDivision of International ComplianceOperationsOffice of ComplianceCenter for Devices and Radiological Health
Regulatory Context
The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter (CMS 461343, dated September 14, 2015). Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The FDA expects your firm to maintain compliance and 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 Corin Ltd?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Corin Ltd 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 Corin Ltd products?
- If you have used products from Corin Ltd 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