# FDA 483 - Gland Pharma Limited, Units I+II Pashamylaram Site - November 07, 2019

Source: https://www.globalkeysolutions.net/records/483/gland-pharma-limited-units-iii-pashamylaram-site/767d64c6-92ff-4f24-8fde-19bd74da6cdc

> FDA 483 for Gland Pharma Limited, Units I+II Pashamylaram Site on November 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited, Units I+II Pashamylaram Site
- Inspection Date: 2019-11-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Gland Pharma Limited, a parenteral drug manufacturer in Patancheru, India, revealed significant deficiencies across multiple areas. Observations included inadequate investigations into discrepancies and foreign materials, insufficient microbial control measures, and failures in laboratory controls for product quality and validation. Additionally, the firm was cited for not taking representative samples of components for testing.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/gland-pharma-limited-units-iii-pashamylaram-site/a7dffca3-c5cc-4802-9cab-54995e7133ca

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