Casmara Cosmetics, S.A. FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 12, 2018
Executive Summary
The FDA issued a warning letter to Casmara Cosmetics, S.A. on February 12, 2018 citing regulatory violations. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Casmara Cosmetics, S.A.'s operations or product claims.
Potential Health Risks
Your procedures to ensure that you test all lots of(b)(4). Provide a current risk assessment of all OTC drug products that contain(b)(4)intended for the U.S. market still within expiry. Provide the results of the testing of retain samples of these lots for(b)(4)and(b)(4).
A current risk assessment of the OTC drug products intended for the U.S. market still within expiry that are not supported by adequate stability testing.
Regulatory Context
Timelines for testing all in-date drug products intended for the U.S., for identity and strength of active ingredients and all other appropriate quality attributes, including total count and objectionable microorganisms. If you find that you released any batch for which release test results were found to be out-of-specification, indicate the corrective actions you will take, such as customer notifications and product recalls.
Timelines for process performance qualification for each of your drug products. For any drugs distributed to the U.S. before validation activities are completed, provide an interim plan to ensure the quality of drug products that you continue to manufacture and distribute. Provide a detailed summary of your approach for routinely monitoring intra-batch and inter-batch variation.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Casmara Cosmetics, S.A.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Casmara Cosmetics, S.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 Casmara Cosmetics, S.A. products?
- If you have used products from Casmara Cosmetics, S.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