# FDA 483 - Lonza Biologics, Inc. - November 03, 2020

Source: https://www.keypedia.com/records/483/lonza-biologics-inc/1c4dc8ba-78a2-4438-b100-d4cfaa927f37

> FDA 483 for Lonza Biologics, Inc. on November 03, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2020-11-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Lonza Biologics Inc., a drug substance manufacturer in Portsmouth, NH, was cited for significant deficiencies during an FDA inspection. Observations included inadequate qualification of a utility system for microbiological control, poorly installed equipment and maintained facilities, and widespread failures to follow or adequately define Standard Operating Procedures across various manufacturing and laboratory operations. These issues indicate a lack of robust quality control and adherence to established protocols.

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## Related Officers

- [Jacek Cieslak](https://www.keypedia.com/people/jacek-cieslak/81b12add-49f1-4dfd-bcb1-60bc5b212b68)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/lonza-biologics-inc/f9882ce5-d92a-4c88-916e-8f4e6d1f2aff

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd