# FDA 483 - Gland Pharma Limited - March 31, 2017

Source: https://www.globalkeysolutions.net/records/483/gland-pharma-limited/a230d37b-da9e-4a02-a664-bd1e0e0caa0d

> FDA 483 for Gland Pharma Limited on March 31, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2017-03-31
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Gland Pharma Limited, a sterile drug manufacturer in Duvvada, Visakhapatnam, was cited for significant deficiencies in its aseptic processing controls and quality system. Observations included inadequate environmental monitoring, insufficient investigations into manufacturing deviations and out-of-specification results, and failures in equipment maintenance and cleaning procedures. These issues indicate a lack of assurance in product quality and process control.

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## Related Officers

- [ Drug Investigator](https://www.globalkeysolutions.net/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd