USFDA concludes inspection at Granules Pharma with zero observations

The inspection was closed with zero observations.

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USFDA United State Food and Drugs Administration
USFDA

Last Updated on January 12, 2024 by The Health Master

Granules India announced that Granules Pharmaceuticals, located in Chantilly, Virginia, has successfully completed the United States Food and Drug Administration (USFDA) Post-Marketing Adverse Drug Experience (PADE) Inspection for all its entities in the US, including Granules India.

The inspection was closed with zero observations on Form 483.

The inspection was conducted at Granules Pharmaceuticals from July 31, 2023, to August 03, 2023.

This inspection covered the Granules’ PADE surveillance, receipts, evaluations, processing, and reporting system for the marketed drug products worldwide.

This is Granules India’s fourth USFDA audit since March, with zero observations.

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