# FDA 483 - Novartis Pharma Stein AG - December 06, 2022

Source: https://www.keypedia.com/records/483/novartis-pharma-stein-ag/e63a23c8-caec-4d2b-9ed3-27a499bfdb25

> FDA 483 for Novartis Pharma Stein AG on December 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharma Stein AG
- Inspection Date: 2022-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Novartis Pharma Stein AG, a drug product manufacturer in Stein Ag, Switzerland, was cited with five observations during an FDA inspection from November 28 to December 6, 2022. The inspection revealed significant deficiencies in aseptic processing procedures, equipment design, process validation, adherence to written procedures, and facility maintenance. These issues indicate a lack of adequate controls to ensure the sterility, quality, and integrity of drug products.

## Related Documents

- [483 - 2017-05-09](https://www.keypedia.com/records/483/novartis-pharma-stein-ag/744bc0b9-9ae9-4b95-8ef6-c6abe8b8f1c6)
- [483 - 2018-09-21](https://www.keypedia.com/records/483/novartis-pharma-stein-ag/7b770256-872c-467d-b840-a8336bd5c659)
- [483 - 2018-12-04](https://www.keypedia.com/records/483/novartis-pharma-stein-ag/3e713a20-3bd1-4991-aad5-bac1eccc2725)

## Related Officers

- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

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