# FDA 483 - Gland Pharma Limited - May 16, 2019

Source: https://www.keypedia.com/records/483/gland-pharma-limited/4fa4ef18-c157-4399-965f-8e1c149ad245

> FDA 483 for Gland Pharma Limited on May 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2019-05-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Gland Pharma Limited, a parenteral drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately investigate unexplained discrepancies, including visible foreign materials in drug products and issues with unclean glassware. Additionally, the inspection identified shortcomings in aseptic processing environmental monitoring, equipment cleaning and sanitization procedures, and contamination control during material transfers.

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## Related Officers

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

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