# FDA 483 - Lonza Tampa LLC - September 29, 2023

Source: https://www.keypedia.com/records/483/lonza-tampa-llc/a8ece597-358f-4cab-bfef-326e617b4a58

> FDA 483 for Lonza Tampa LLC on September 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Tampa LLC
- Inspection Date: 2023-09-29
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Lonza Tampa LLC, a drug manufacturer, was cited for deficiencies in its quality control unit's procedures. The firm failed to thoroughly investigate cleaning residue failures by identifying a root cause and establishing appropriate preventative measures. Out of 48 cleaning verification swab failures, 45 deviation reports lacked an assignable root cause.

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## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [ CSO](https://www.keypedia.com/people/megan-t-ziegler/3e83a317-701a-4e40-bb43-34d294d3448f)
- [Suzanne B Valdez](https://www.keypedia.com/people/suzanne-b-valdez/e0dd13bc-023e-47ec-850c-95bdde545002)

Company: https://www.keypedia.com/companies/lonza-tampa-llc/6ba00e57-ba56-45fd-9718-cb91a9b2458a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6