# FDA 483 - BSP Pharmaceuticals SpA - Unknown Date

Source: https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/6d9334e4-355f-4e21-ad72-92357fb9a296

> FDA 483 for BSP Pharmaceuticals SpA on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSP Pharmaceuticals SpA
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: An FDA inspection of BSP Pharmaceuticals S.p.A. in Latina Scalo LT, Italy, a drug substance and drug product manufacturing facility, revealed significant issues. Observations included discrepancies between facility documentation and actual operations, inadequate pressure monitoring during drug product manufacturing, and an insufficient procedure for handling out-of-specification results. These findings indicate deficiencies in quality control and manufacturing process oversight.

## Related Documents

- [483 - 2022-03-23](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/68fa82b3-986f-4e5c-8ec1-dd7c474a41b0)
- [483 - 2024-02-29](https://www.keypedia.com/records/483/bsp-pharmaceuticals-spa/58fbfc2c-ad6a-42b3-9087-1c14bd326f71)

## Related Officers

- [Jessica Hankins](https://www.keypedia.com/people/jessica-hankins/199a210e-6fa6-4d96-928d-4eee36658454)
- [investigator](https://www.keypedia.com/people/ephrem-hunde/3c582fce-ff16-49e8-9594-34d19b7c524e)
- [investigator](https://www.keypedia.com/people/reyes-candau-chacon/f45d84c3-da5c-4958-bee8-084883ce8fef)
- [Rachel Novak](https://www.keypedia.com/people/rachel-novak/f5e51188-139d-499c-a066-b5ca0d7ee431)

Company: https://www.keypedia.com/companies/bsp-pharmaceuticals-spa/cbf52ec3-50e2-4cf1-9f81-f0f7a74473fc

Office: https://www.keypedia.com/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591