# FDA 483 - Industria Farmaceutica Galenica Senese Srl - July 01, 2022

Source: https://www.keypedia.com/records/483/industria-farmaceutica-galenica-senese-srl/e64a5500-c52a-4fdf-a175-b78dc6bcadeb

> FDA 483 for Industria Farmaceutica Galenica Senese Srl on July 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Industria Farmaceutica Galenica Senese Srl
- Inspection Date: 2022-07-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Industria Farmaceutica Galenica Senese Srl in Monteroni D'Arbia, Siena, revealed significant deficiencies in quality control and record-keeping. The firm failed to adequately investigate out-of-specification results and lacked complete master production and control records. These issues indicate a need for improved quality system oversight.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/industria-farmaceutica-galenica-senese-srl/ebf6e580-3c75-4b96-8fb8-04af6e361468)

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1