Sato Yakuhin Kogyo Co., Ltd. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 06, 2017
Executive Summary
The FDA issued a warning letter to Sato Yakuhin Kogyo Co., Ltd. on January 06, 2017 citing cgmp violations. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
Your plan for revalidating the(b)(4)system after you changed the flexible tank delivery lines to prevent(b)(4)when not in use, removed the dead legs, and began monitoring(b)(4). When revalidation is completed, provide a validation report.
Potential Health Risks
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionavailable online athttp://www.fda.gov/downloads/Drugs/.../Guidances/ucm070287.pdf
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
Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance – Records and Reportsavailable online athttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124787.htm.
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 detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all of the data you generate, including analytical data, manufacturing records, and all data submitted to FDA.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Sato Yakuhin Kogyo Co., Ltd.?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are Sato Yakuhin Kogyo Co., Ltd. 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 Sato Yakuhin Kogyo Co., Ltd. products?
- If you have used products from Sato Yakuhin Kogyo 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