Badrivishal Chemicals & Pharmaceuticals FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 02, 2017
Executive Summary
The FDA issued a warning letter to Badrivishal Chemicals & Pharmaceuticals on March 02, 2017 citing cgmp violations. The letter was issued by Center for Drug Evaluation and Research.
Detailed Analysis
False Claims and Regulatory Violations
corrective and preventive actions if source water test results exceed the limits
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
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.
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 Badrivishal Chemicals & Pharmaceuticals?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are Badrivishal Chemicals & Pharmaceuticals 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 Badrivishal Chemicals & Pharmaceuticals products?
- If you have used products from Badrivishal Chemicals & Pharmaceuticals 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