Divi's Laboratories Ltd. (Unit II) FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 13, 2017
Executive Summary
The FDA issued a warning letter to Divi's Laboratories Ltd. (Unit II) on April 13, 2017 citing cgmp 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 Divi's Laboratories Ltd. (Unit II)'s operations or product claims.
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 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.
Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Divi's Laboratories Ltd. (Unit II)?
- The FDA issued a warning letter citing cgmp violations related to their products or manufacturing practices.
- Are Divi's Laboratories Ltd. (Unit II) 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 Divi's Laboratories Ltd. (Unit II) products?
- If you have used products from Divi's Laboratories Ltd. (Unit II) 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