# FDA 483 - Lonza Tampa LLC - October 01, 2021

Source: https://www.keypedia.com/records/483/lonza-tampa-llc/252f0240-687e-4549-aebb-d7383ba3caf8

> FDA 483 for Lonza Tampa LLC on October 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza Tampa LLC
- Inspection Date: 2021-10-01
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Xcelience LLC, a drug manufacturer in Tampa, FL, was cited for significant deficiencies in its quality control unit and master production and control records. The inspection revealed failures to thoroughly investigate deviations and cleaning issues, leading to the release of non-conforming product. Additionally, master records lacked complete instructions for manufacturing and sampling of finished drug products.

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## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Susanne M Valles](https://www.keypedia.com/people/susanne-m-valles/aa2f6bd1-6eff-4388-a214-c21f14413ab9)
- [Lillian M Colon-McKnight](https://www.keypedia.com/people/lillian-m-colon-mcknight/ce6346b7-a006-4f84-afba-9fdda488042d)

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