Is Seiki Co., Ltd. Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on June 01, 2017
Executive Summary
The FDA issued a warning letter to Seiki Co., Ltd. on June 01, 2017 citing regulatory violations. The letter was issued by Center for Food Safety and Applied Nutrition.
Detailed Analysis
False Claims and Regulatory Violations
The method of storage and distribution listed in the heading of your HACCP plan of “(b)(4)” is not adequate. Refrigerated vacuum and reduced oxygen packaged fresh fish must be continuously maintained at temperatures of 3.3°C or below to prevent the hazard ofC. botulinumgrowth and toxin formation during all subsequent distribution until the individual packages are opened.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Seiki Co., Ltd..
Regulatory Context
Your critical limit at the “TTI Activation Test” critical control point to controlC. botulinumtoxin formation states "(b)(4)”, however, you do not indicate what determines if the(b)(4), for example if the TTI produces an alert indicator, such as a color change of the device when exposed to time and temperature abuse.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Seiki Co., Ltd.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Seiki Co., Ltd. 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 Seiki Co., Ltd. products?
- If you have used products from Seiki 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