What did the FDA find wrong with Bicooya Cosmetics Limited?

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

Are Bicooya Cosmetics Limited 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 Bicooya Cosmetics Limited products?

If you have used products from Bicooya Cosmetics Limited and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Bicooya Cosmetics Limited FDA Warning (2017)

Name: Bicooya Cosmetics Limited FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:20.960870

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 11, 2017

MODERATE SEVERITY Center for Drug Evaluation and Research 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 Bicooya Cosmetics Limited on August 11, 2017 citing cgmp violations. The letter was issued by Center for Drug Evaluation and Research.

CGMP Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Bicooya Cosmetics Limited's operations or product claims.

Potential Health Risks

A comprehensive description of the root causes of your data integrity lapses, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.

Regulatory Context

in direct proximity to the filling machine where you manufacture OTC drug products

A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.

A comprehensive retrospective evaluation of the nature of the testing and manufacturing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.

Key Entities Identified

Bicooya Cosmetics Limited FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Bicooya Cosmetics Limited?: The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
Are Bicooya Cosmetics Limited 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 Bicooya Cosmetics Limited products?: If you have used products from Bicooya Cosmetics Limited 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.