# FDA 483 - Oy Finnsusp Ab - April 03, 2023

Source: https://www.keypedia.com/records/483/oy-finnsusp-ab/6f299c4a-fd9a-4a8f-aa82-30ad92d3cbf3

> FDA 483 for Oy Finnsusp Ab on April 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oy Finnsusp Ab
- Inspection Date: 2023-04-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Oy Finnsusp Ab, an OTC drug manufacturer in Lieto, Finland, was inspected and cited for significant deficiencies across multiple systems. Observations included inadequate batch production records, failure to prevent contamination in the water system, deficient OOS investigations, and issues with reserve sample management. Additionally, the firm failed to follow procedures for preventing microbiological contamination in sterile drug production and lacked equivalent visual inspection procedures.

## Related Officers

- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.keypedia.com/companies/oy-finnsusp-ab/77b4381c-909d-4d9f-8f30-9ad92452b2d4

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