# FDA 483 - Steriscience SP. Z O.O. - April 28, 2023

Source: https://www.keypedia.com/records/483/steriscience-sp-z-oo/f77e31bb-20ee-49aa-8782-a71ae8148e2f

> FDA 483 for Steriscience SP. Z O.O. on April 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steriscience SP. Z O.O.
- Inspection Date: 2023-04-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Steriscience Sp. z o.o. in Warsaw, Poland, revealed significant deficiencies in their manufacturing processes for sterile drug products. Observations included inadequate training and qualification of visual inspectors, scientifically unsound laboratory controls for microbial enumeration, and insufficient procedures to prevent microbiological contamination. These issues raise concerns about the quality and sterility assurance of their drug products.

## Related Officers

- [Xiaokuang Lai](https://www.keypedia.com/people/xiaokuang-lai/6c25851d-0954-4f42-8f14-c2e0382e6815)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/steriscience-sp-z-oo/a2c32aee-8f5f-4bd3-8cc9-9fdcf970ebf4

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