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

Source: https://www.keypedia.com/records/483/gland-pharma-limited/56cd5b1f-5d10-4fea-b13f-c9d3d980f6d4

> 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 Biological Products Operations - Division I
- Summary: An FDA inspection of Gland Pharma Limited in Hyderabad, India, identified two significant observations. The firm's quality control unit failed to adequately follow written procedures for monitoring and responding to non-viable particle count excursions. Additionally, the company did not maintain production and control records, specifically CCTV footage of aseptic processing, for the required duration after the drug product's expiration date.

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- [483 - 2023-07-14](https://www.keypedia.com/records/483/gland-pharma-limited/a8b23a0b-1439-46db-b7a7-ac096d7940c7)

## Related Officers

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

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

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