# FDA 483 - Gland Pharma Limited - July 25, 2024

Source: https://www.keypedia.com/records/483/gland-pharma-limited/a1d0389a-8f1b-419e-aa72-90e50dbc4369

> FDA 483 for Gland Pharma Limited on July 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2024-07-25
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Gland Pharma Limited, a human drug manufacturer in Hyderabad, India, from July 22-25, 2024, revealed significant deficiencies. The firm failed to adequately follow and document quality control procedures for monitoring non-viable particle count excursions. Additionally, critical production and control records, specifically CCTV footage of aseptic operations, were not retained for the required duration.

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- [EIR - 2025-08-25](https://www.keypedia.com/records/eir/gland-pharma-limited/782a11ea-4dcf-4e82-beb1-39459e334adf)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3