# FDA 483 - Sentiss Pharma Pvt. Ltd. - May 23, 2017

Source: https://www.keypedia.com/records/483/sentiss-pharma-pvt-ltd/82a7a1be-a10d-471d-92f0-f20ac54177e7

> FDA 483 for Sentiss Pharma Pvt. Ltd. on May 23, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sentiss Pharma Pvt. Ltd.
- Inspection Date: 2017-05-23
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: Geniss Pharma Pvt. Ltd., a sterile drug manufacturer in District Solan, India, was inspected by the FDA, revealing significant deficiencies. The inspection highlighted inadequate investigations into discrepancies and data integrity issues, failures in aseptic processing procedures, and a lack of proper quality control and change control. Laboratory controls were also found to be deficient, with issues in specifications, testing, and record-keeping.

## Related Documents

- [483 - 2017-05-23](https://www.keypedia.com/records/483/sentiss-pharma-pvt-ltd/af6f2cf8-d297-4949-bf50-7adf178caadb)

## Related Officers

- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/sentiss-pharma-pvt-ltd/9b26b814-70c1-46e9-bc82-9bec425fd2b7

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917