# FDA 483 - NextPharma OY - September 06, 2022

Source: https://www.keypedia.com/records/483/nextpharma-oy/04b35e81-9a7d-4db3-bc47-7caab88c6090

> FDA 483 for NextPharma OY on September 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NextPharma OY
- Inspection Date: 2022-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: NextPharma OY, a contract sterile drug manufacturer in Tampere, Finland, received a Form 483 with six observations related to significant deficiencies in manufacturing process controls, sterilization validation, aseptic practices, equipment maintenance, facility repair, and environmental monitoring. These issues indicate a lack of readiness for commercial sterile drug product manufacturing and potential risks to product quality and sterility.

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.keypedia.com/companies/nextpharma-oy/5b55d776-23ac-485d-bcb8-0a0c74091608

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