# FDA 483 - Gland Pharma Limited, Units I+II Pashamylaram Site - August 02, 2024

Source: https://www.globalkeysolutions.net/records/483/gland-pharma-limited-units-iii-pashamylaram-site/ec9c17b8-eaa1-4d9f-aa4a-0631bfca1f54

> FDA 483 for Gland Pharma Limited, Units I+II Pashamylaram Site on August 02, 2024. Product: drugs. 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: 2024-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Gland Pharma Limited, Units I+II in Hyderabad, India, from July 25 to August 2, 2024, revealed significant deficiencies in the manufacturing of sterile drug products. The firm was cited for inadequate aseptic processing simulations, poor environmental monitoring practices, and a quality control unit that failed to properly follow procedures, leading to repeated equipment breakdowns and out-of-specification results.

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- [483 - 2023-08-26](https://www.globalkeysolutions.net/records/483/gland-pharma-limited-units-iii-pashamylaram-site/c2f4d2bb-1f08-4cc0-b659-19378e201a83)
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## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1