# FDA 483 - Novartis Pharma AG - August 30, 2022

Source: https://www.globalkeysolutions.net/records/483/novartis-pharma-ag/7020c2fe-862b-4517-b28a-f6b34cd39f2d

> FDA 483 for Novartis Pharma AG on August 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Pharma AG
- Inspection Date: 2022-08-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Novartis Pharma AG, a drug substance manufacturer in Basel, Switzerland, received three observations during an FDA inspection. The inspection identified deficiencies related to inadequate controls for computerized systems, insufficient qualification of equipment used for stability sample storage, and a lack of adequate reserve samples for quality control analysis. These findings highlight concerns with data integrity, equipment validation, and quality control procedures at the facility.

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.globalkeysolutions.net/companies/novartis-pharma-ag/194ac641-5956-4430-9641-411cb975a51f

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