# FDA 483 - Janssen - Cilag Spa. - January 21, 2019

Source: https://www.keypedia.com/records/483/janssen-cilag-spa/5ae9e9fd-66eb-46e4-abec-fe3e29f48687

> FDA 483 for Janssen - Cilag Spa. on January 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Janssen - Cilag Spa.
- Inspection Date: 2019-01-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Janssen Cilag via C. Janssen snc in Latina, Italy, revealed significant deficiencies in laboratory controls and data integrity. The firm failed to ensure the accuracy and reliability of test results, specifically regarding the integration and reporting of degradation peaks for tablet batches. Additionally, the Empower chromatographic system software was found to be inadequately configured, with unspecified integration parameters that could prevent the detection of critical components in pharmaceutical products.

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.keypedia.com/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)
- [Steve Rhee](https://www.keypedia.com/people/steve-rhee/d5065fb5-8e22-44ef-be92-c8d52e7ed143)

Company: https://www.keypedia.com/companies/janssen-cilag-spa/56d16030-02d8-414b-8438-54033c2e5f91

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