Drug Approval | March 22, 2023
Granules Consumer Health concludes FDA audit with zero observations
The audit is a pre-approval inspection for three products filed from the facility
The audit is a pre-approval inspection for three products filed from the facility
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
The company had responded to the agency and carried out the required corrective actions.
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
There are no data integrity (DI) observations.
he US FDA has issued six observations pursuant to the completion of the audit.
The company has responded to the warning letter and carried out the committed corrections.
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
A total of five observations for Goa and 17 for Monroe
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