# FDA 483 - Lonza Walkersville, Inc. - November 05, 2021

Source: https://www.keypedia.com/records/483/lonza-walkersville-inc/f49b1490-32bf-46e4-b70d-b4d92acebfc2

> FDA 483 for Lonza Walkersville, Inc. on November 05, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Walkersville, Inc.
- Inspection Date: 2021-11-05
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Lonza Walkersville, Inc., a medical device and biologics manufacturer, was cited with six observations during an FDA inspection from November 1-5, 2021. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for CAPA, process validation, complaint handling, contamination control, and nonconforming product disposition. These issues indicate a systemic failure to maintain robust quality control and regulatory compliance.

## Related Documents

- [483 - 2016-06-09](https://www.keypedia.com/records/483/lonza-walkersville-inc/af980e2e-0203-40b8-b497-25de076346a1)
- [483 - 2017-02-06](https://www.keypedia.com/records/483/lonza-walkersville-inc/fa310eef-2331-4a96-b87d-2baba8c9f765)

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/lonza-walkersville-inc/5008199b-623e-432c-942c-db06b6333f53

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64