# FDA 483 - Gland Pharma Limited, Units I+II Pashamylaram Site - August 26, 2023

Source: https://www.globalkeysolutions.net/records/483/gland-pharma-limited-units-iii-pashamylaram-site/c2f4d2bb-1f08-4cc0-b659-19378e201a83

> FDA 483 for Gland Pharma Limited, Units I+II Pashamylaram Site on August 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited, Units I+II Pashamylaram Site
- Inspection Date: 2023-08-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Gland Pharma Limited in Hyderabad, India, a device manufacturer, was inspected by the FDA from August 23-26, 2023. The inspection revealed two significant issues: inadequate qualification of manufacturing equipment for Liraglutide Injection devices and failures in maintaining quality system records. These observations indicate deficiencies in both equipment validation and data management practices, including improper computer access.

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## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/gland-pharma-limited-units-iii-pashamylaram-site/a7dffca3-c5cc-4802-9cab-54995e7133ca

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