# FDA 483 - PCAS Finland Oy - June 07, 2024

Source: https://www.keypedia.com/records/483/pcas-finland-oy/a4cf5446-2b4b-4f84-8402-1c6b9c3beec3

> FDA 483 for PCAS Finland Oy on June 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PCAS Finland Oy
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of PCAS Finland Oy, an API manufacturer in Turku, revealed significant deficiencies in quality control and facility maintenance. The firm failed to investigate unknown impurities detected by an in-house method and lacked established maintenance procedures for critical manufacturing equipment. Additionally, the inspection found poorly maintained manufacturing spaces and equipment in bioburden-controlled areas, including structural damage and compromised airflow.

## Related Documents

- [483 - 2019-09-13](https://www.keypedia.com/records/483/pcas-finland-oy/7b834bfa-b546-48d8-8742-08c28c804e1d)
- [483 - 2024-06-07](https://www.keypedia.com/records/483/pcas-finland-oy/d2b356c4-7b1c-4bd8-aafc-d3b75e123c49)

## Related Officers

- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

Company: https://www.keypedia.com/companies/pcas-finland-oy/19918537-642f-4d1a-a55b-d8c267e069df

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917