# FDA 483 - Gland Pharma Limited - November 01, 2019

Source: https://www.keypedia.com/records/483/gland-pharma-limited/cb276665-92aa-427d-b63e-73e0bdec767a

> FDA 483 for Gland Pharma Limited on November 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2019-11-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Gland Pharma Limited, a sterile drug manufacturer in Visakhapatnam, revealed two significant observations. The firm failed to adequately validate its aseptic and sterilization processes, raising concerns about microbiological contamination control. Additionally, investigations into unexplained discrepancies lacked thoroughness, conclusions, and follow-up actions.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.keypedia.com/companies/gland-pharma-limited/9d02bb1e-32f9-45c5-9b90-f52622553c63

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