# FDA 483 - GlaxoSmithKline Vaccines S.r.l. - June 06, 2019

Source: https://www.globalkeysolutions.net/records/483/glaxosmithkline-vaccines-srl/b5f44ae2-4e3a-42a8-bb3e-bf243053fa45

> FDA 483 for GlaxoSmithKline Vaccines S.r.l. on June 06, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Vaccines S.r.l.
- Inspection Date: 2019-06-06
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of GlaxoSmithKline Vaccines S.r.l. in Siena, Italy, identified three observations. The firm was cited for inadequate control procedures, specifically lacking hold time validations for laboratory materials. Additionally, issues were noted with the identification of lots and deficiencies in equipment cleaning and maintenance procedures, including an inadequately maintained freezer.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/darla-j-christopher/64d3f47f-f3c0-4cfd-a3e8-4dc0e69d04bd)
- [issuing_officer](https://www.globalkeysolutions.net/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

Company: https://www.globalkeysolutions.net/companies/glaxosmithkline-vaccines-srl/cddb07b7-c8a6-4dbd-a92c-c6ebeeb7e009

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321