# FDA 483 - Novartis Pharma Stein AG - May 09, 2017

Source: https://www.keypedia.com/records/483/novartis-pharma-stein-ag/744bc0b9-9ae9-4b95-8ef6-c6abe8b8f1c6

> FDA 483 for Novartis Pharma Stein AG on May 09, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharma Stein AG
- Inspection Date: 2017-05-09
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Novartis Pharma Stein AG, a drug manufacturer in Stein AG, Switzerland, was inspected by the FDA from May 1-9, 2017. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory testing and release procedures, insufficient investigations into failed batches, and critical issues with data integrity and equipment calibration. Additionally, the firm failed to prevent microbiological contamination, properly quarantine materials, and assign unique batch numbers, with the latter being a repeat observation.

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## Related Officers

- [Ademola O. Daramola](https://www.keypedia.com/people/ademola-o-daramola/814113a4-38bc-4ce5-b6af-09c7e688c0ec)
- [investigator](https://www.keypedia.com/people/don-h-bark/c91b02bc-f735-46d8-a0ef-b44724868908)

Company: https://www.keypedia.com/companies/novartis-pharma-stein-ag/06be1f01-8421-471e-9d38-475fef9a9c5b

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321