# FDA 483 - GlaxoSmithKline Manufacturing S.p.A. - Unknown Date

Source: https://www.keypedia.com/records/483/glaxosmithkline-manufacturing-spa/f695d0d3-6b06-48cd-b6b1-9301b4035d0e

> FDA 483 for GlaxoSmithKline Manufacturing S.p.A. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlaxoSmithKline Manufacturing S.p.A.
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: GlaxoSmithKline Manufacturing S.p.A., a drug product manufacturer in San Polo di Torrile, Parma, Italy, was cited for significant deficiencies in its aseptic processing operations during an FDA inspection. The inspection revealed multiple instances where Standard Operating Procedures were either inadequate or not followed, leading to potential contamination risks in critical manufacturing areas. These issues included improper material handling, inadequate sanitization practices, and insufficient personnel and environmental monitoring.

## Related Documents

- [483 - 2025-05-15](https://www.keypedia.com/records/483/glaxosmithkline-manufacturing-spa/ac7ed7b6-0c73-4492-9e81-44547f9e5440)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/glaxosmithkline-manufacturing-spa/11f7427f-c02e-4b80-91dd-f90cbe9b90a9

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0