What did the FDA find wrong with FACTA Farmaceutici S.p.A.?

The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.

Are FACTA Farmaceutici S.p.A. 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 FACTA Farmaceutici S.p.A. products?

If you have used products from FACTA Farmaceutici 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.

FACTA Farmaceutici S.p.A. FDA Warning (2017)

Name: FACTA Farmaceutici S.p.A. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:21.147904

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 25, 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 FACTA Farmaceutici S.p.A. on August 25, 2017 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in FACTA Farmaceutici S.p.A.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from FACTA Farmaceutici S.p.A..

Regulatory Context

Davide GulluaQuality Unit DirectorFACTA Farmaceutici S.p.A.Nucleo Ind. Le S. AttoSan Nicolo a Tordino 64100 (TE), Italy

Location: FACTA Farmaceutici S.p.A.Zona Industriale Sant’ Atto S NTerramo, Teramo, 64100, Italy

The Food and Drug Administration has completed an evaluation of FACTA Farmaceutici S.p.A. (FEI 3006028606) corrective actions in response to Warning Letter 320-17-17, dated January 01, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

Key Entities Identified

FACTA Farmaceutici S.p.A. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with FACTA Farmaceutici S.p.A.?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are FACTA Farmaceutici S.p.A. 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 FACTA Farmaceutici S.p.A. products?: If you have used products from FACTA Farmaceutici 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.