Is Firson Co., Ltd. Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on August 31, 2017
Executive Summary
The FDA issued a warning letter to Firson Co., Ltd. on August 31, 2017 citing contamination. Consumers who have purchased products from this company should exercise caution. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
Provide a comprehensive review of your media fill program and corrective and preventive actions (CAPA) to ensure an appropriate simulation of the worst-case conditions of commercial manufacturing. Also detail how you examine units for presence of growth, and perform batch yield reconciliation.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Firson Co., Ltd..
Regulatory Context
Provide an action plan and timelines for implementing corrective actions, including notifying your customers and recalling any(b)(4)ointment drug products within expiry that were distributed to the U.S. and manufactured without adequate sterilization.
Provide your environmental and personnel monitoring procedures. Justify monitoring locations, frequency, and action limits.
Summarize the actions you have taken to comprehensively remediate your complaint investigation process. Include your revised investigation procedure(s) and the actions you are taking to ensure that your staff follows these procedures.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Firson Co., Ltd.?
- The FDA issued a warning letter citing contamination related to their products or manufacturing practices.
- Are Firson Co., Ltd. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have contamination that may affect product safety.
- What should I do if I've used Firson Co., Ltd. products?
- If you have used products from Firson Co., 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