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Corden Pharma Latina S.p.A. FDA Warning (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 17, 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 Corden Pharma Latina S.p.A. on August 17, 2017 citing cgmp violations. The letter was issued by the FDA.

CGMP Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Corden Pharma Latina S.p.A.'s operations or product claims.

Potential Health Risks

Emilio Frongia, Managing DirectorCorden Pharma S.p.AVia del Murillo Km 2800Sermoncta, Latina, Italy, 04013

Regulatory Context

The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter: 320-16-14 dated May 20, 2016. Based on our evaluation, it appears that you have addressed the violations and/or deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will fu rther assess the adequacy and sustainability of these corrections.

This letter does not relieve you or 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 or with other relevant legal authority. The FDA expects you and your firm to maintain compliance with current good manufacturing practices and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations and/or deviations be observed during a subsequent inspection or through other means.

/S/Matthew SchnuppCompliance OfficerDivision of Drug Quality II

Key Entities Identified

Corden Pharma Latina S.p.A. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Corden Pharma Latina S.p.A.?
The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
Are Corden Pharma Latina S.p.A. products safe to use?
Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.
What should I do if I've used Corden Pharma Latina S.p.A. products?
If you have used products from Corden Pharma Latina S.p.A. 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.