# FDA 483 - Lonza Walkersville, Inc. - June 09, 2016

Source: https://www.globalkeysolutions.net/records/483/lonza-walkersville-inc/af980e2e-0203-40b8-b497-25de076346a1

> FDA 483 for Lonza Walkersville, Inc. on June 09, 2016. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Walkersville, Inc.
- Inspection Date: 2016-06-09
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lonza Walkersville, Inc., a licensed LAL manufacturer in Walkersville, MD, was cited for inadequate corrective actions regarding sterility failures, with multiple instances of gram-positive organism contamination. Additionally, the inspection revealed insufficient control over packaging and labeling operations, which led to mix-ups of endotoxin vials in LAL kits and subsequent Biological Product Deviation Reports. These findings indicate significant issues in quality control and manufacturing processes.

## Related Documents

- [483 - 2017-02-06](https://www.globalkeysolutions.net/records/483/lonza-walkersville-inc/fa310eef-2331-4a96-b87d-2baba8c9f765)
- [483 - 2021-11-05](https://www.globalkeysolutions.net/records/483/lonza-walkersville-inc/f49b1490-32bf-46e4-b70d-b4d92acebfc2)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

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

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