# FDA 483 - Gland Pharma Limited - March 17, 2015

Source: https://www.keypedia.com/records/483/gland-pharma-limited/e76b5f6e-2c1e-45b0-9c0e-e037a8f686a1

> FDA 483 for Gland Pharma Limited on March 17, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gland Pharma Limited
- Inspection Date: 2015-03-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Gland Pharma Limited in Hyderabad, India, revealed deficiencies in their quality system. The firm's procedures for annual quality standards record evaluation were found to be inadequate, specifically regarding the tracking and trending of QC laboratory incident reports. Additionally, investigations into unexplained discrepancies lacked complete conclusions and follow-up, including insufficient preventive actions for out-of-specification observations.

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## Related Officers

- [Senior Consumer Safety Officer](https://www.keypedia.com/people/carla-j-lundi/a10ed698-54fe-4635-a766-8c31f501dfb2)

Company: https://www.keypedia.com/companies/gland-pharma-limited/dd730d79-1c97-4fb0-b717-c0ebd71a5b3f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8