# FDA 483 - Gland Pharma Limited - July 14, 2023

Source: https://www.globalkeysolutions.net/records/483/gland-pharma-limited/a8b23a0b-1439-46db-b7a7-ac096d7940c7

> FDA 483 for Gland Pharma Limited on July 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2023-07-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Gland Pharma Limited in Hyderabad, India, from July 3-14, 2023, revealed significant deficiencies in laboratory record-keeping. The firm failed to maintain complete data for various product tests, including injections, sub-visible particles, and sterility testing. These issues indicate a lack of adherence to established specifications and standards for laboratory controls.

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## Related Officers

- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
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Company: https://www.globalkeysolutions.net/companies/gland-pharma-limited/dd730d79-1c97-4fb0-b717-c0ebd71a5b3f

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