- A company submitted study data supporting a PMA submission to the FDA.
- Granules India Limited is submitting ANDA and Paragraph IV certification to the FDA.
USFDA Issues 483 Observations Following Facility Inspection
What happened
The United States Food and Drug Administration conducted a current Good Manufacturing Practice inspection at a finished dosage facility in Hyderabad between October 19 and October 30, 2026. The agency concluded the inspection by issuing a Form FDA 483 containing eleven observations. These observations related to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls, and documentation practices. The facility stated that there is no impact on the manufacturing or distribution of products from the site.
From moneycontrol.com
Why it matters
The inspection occurred while the facility was submitting ANDA and Paragraph IV certification to the FDA. The observations, while not related to data integrity or cross-contamination, require the company to submit a comprehensive response and corrective actions to the agency within 15 business days.
Granules India Limited is submitting ANDA and Paragraph IV certification to the FDA.
From moneycontrol.com
Who's involved
- United States Food and Drug AdministrationConducted the cGMP inspection and issued the Form FDA 483.
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The entities involved
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United States Food and Drug Administration
agency of the US Department of Health and Human Services
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