# FDA 483 - Lonza Biologics, Inc. - October 22, 2021

Source: https://www.globalkeysolutions.net/records/483/lonza-biologics-inc/6e82b09e-669e-408f-9fb6-6063c2bbc0b0

> FDA 483 for Lonza Biologics, Inc. on October 22, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Biologics, Inc.
- Inspection Date: 2021-10-22
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, a vaccine drug substance manufacturer, revealed significant deficiencies. Observations included untimely investigations into deviations, improper handling of human errors during validation, and poor facility maintenance with issues like wall damage, gaps in doors, pest presence, and growth-like material. Additionally, the facility failed to timely repair numerous leaking pipes and equipment, indicating a lack of control over its infrastructure.

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## Related Officers

- [Obina Echeozo](https://www.globalkeysolutions.net/people/obina-echeozo/7d5adbd7-367a-4426-9f14-69efd812fc6b)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/pete-amin/7f032e7a-1dfc-4240-ba8d-2bba5f7e5b6b)

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

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