# FDA 483 - Gland Pharma Limited - August 25, 2022

Source: https://www.keypedia.com/records/483/gland-pharma-limited/cbd5ee58-0d35-4dc8-a3c5-c1f424b4f63a

> FDA 483 for Gland Pharma Limited on August 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2022-08-25
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Gland Pharma Limited, a drug-device combination manufacturer in Hyderabad, India, received a Form FDA 483 for deficiencies in its quality system. The inspection revealed that the firm had not established adequate procedures for design control, specifically failing to define design input requirements and ensure scientific justification for its Icatibant Injection product. Furthermore, the company had not fully implemented its quality risk management procedure, leading to an incomplete identification of potential faults and hazards.

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## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/gland-pharma-limited/dd730d79-1c97-4fb0-b717-c0ebd71a5b3f

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd