# FDA 483 - Cilag AG - September 23, 2024

Source: https://www.keypedia.com/records/483/cilag-ag/114092e8-2db7-42e9-a655-7fd49de1a4b6

> FDA 483 for Cilag AG on September 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cilag AG
- Inspection Date: 2024-09-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Cilag AG, a drug product manufacturer in Schaffhausen, Switzerland, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination of sterile drug products, insufficient environmental monitoring in aseptic processing areas, and failures in assuring drug product quality through proper visual inspection and equipment maintenance. These issues indicate a lack of control over critical manufacturing processes and quality systems.

## Related Documents

- [483 - 2019-07-16](https://www.keypedia.com/records/483/cilag-ag/24f39902-f5af-47ce-b648-514441b550a8)
- [483 - 2025-06-16](https://www.keypedia.com/records/483/cilag-ag/537b1473-d6a2-423b-ab58-5fa704f72354)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Hyung-yul Lee](https://www.keypedia.com/people/hyung-yul-lee/a790a804-2e43-4901-8d7d-0c656c464f0f)
- [investigator](https://www.keypedia.com/people/cassandra-l-abellard/e27aef11-adc6-449b-b7a8-f4c419549467)

Company: https://www.keypedia.com/companies/cilag-ag/acb7f670-89b9-4e40-a784-ed06b0282362

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8