# FDA 483 - Industria Farmaceutica Galenica Senese Srl - Unknown Date

Source: https://www.keypedia.com/records/483/industria-farmaceutica-galenica-senese-srl/ebf6e580-3c75-4b96-8fb8-04af6e361468

> FDA 483 for Industria Farmaceutica Galenica Senese Srl on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Industria Farmaceutica Galenica Senese Srl
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspection of Industria Farmaceutica Galencia Senese SRL in Monteroni D'Arbia, Siena, Italy, revealed significant deficiencies across multiple areas of sterile drug product manufacturing. Key issues included a lack of consistency and reproducibility in injection batch production, incomplete stability records, and inadequate investigations into out-of-specification results. The firm also failed to establish proper controls for microbiological contamination, maintain environmental monitoring, and ensure adequate equipment calibration and temperature/humidity control, indicating a serious lack of quality assurance.

## Related Documents

- [483 - 2022-07-01](https://www.keypedia.com/records/483/industria-farmaceutica-galenica-senese-srl/e64a5500-c52a-4fdf-a175-b78dc6bcadeb)

## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.keypedia.com/companies/industria-farmaceutica-galenica-senese-srl/0d49d76f-5718-4021-a5b5-a3144c3fc1cc

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