USFDA Inspection: At Granules India with Zero observations

A flawless USFDA inspection bolsters Granules India's reputation as a reliable and high-quality pharmaceutical manufacturer.

USFDA Inspection audit
USFDA Inspection

Last Updated on April 26, 2024 by The Health Master

USFDA Inspection

Granules India Limited, a leading pharmaceutical manufacturer, has achieved a significant milestone with its Unit V facility located in Anakapally, Visakhapatnam, India. The facility recently underwent a rigorous USFDA inspection and emerged with flying colors, receiving zero 483 observations.

This accomplishment signifies Granules India’s unwavering dedication to meeting the highest quality standards for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs) across oncology and non-oncology product lines.

Understanding the Significance of the USFDA Inspection

The US Food and Drug Administration (USFDA) is a highly respected regulatory body that oversees the safety and efficacy of drugs in the United States.

A pre-approval inspection (PAI) is a critical step for pharmaceutical facilities seeking to export drugs to the US market.

During this inspection, USFDA inspectors meticulously evaluate a facility’s compliance with Current Good Manufacturing Practices (cGMP) regulations.

These regulations encompass a wide range of aspects, including:

  • Quality control procedures
  • Manufacturing processes
  • Documentation practices
  • Facility and equipment maintenance

A successful USFDA inspection with zero 483 observations indicates that the inspected facility has met all the USFDA’s cGMP requirements.

This achievement is a strong testament to Granules India’s commitment to excellence in pharmaceutical manufacturing.

Benefits of Granules India’s Flawless USFDA Inspection

Granules India’s success in the USFDA inspection presents several advantages:

  • Enhanced Market Access: This approval paves the way for Granules India to expand its reach into the lucrative US market for oncology and non-oncology drugs.
  • Stronger Reputation: A flawless USFDA inspection bolsters Granules India’s reputation as a reliable and high-quality pharmaceutical manufacturer.
  • Increased Investor Confidence: This positive outcome can instill greater confidence among investors in Granules India’s future prospects.


Granules India’s Unit V facility’s exceptional outcome from the USFDA inspection is a noteworthy accomplishment.

This achievement underscores the company’s dedication to manufacturing high-quality pharmaceutical products that meet stringent international standards.

By prioritizing quality and compliance, Granules India is well-positioned to become a major player in the global pharmaceutical market.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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