# FDA 483 - PCAS Finland Oy - September 13, 2019

Source: https://www.globalkeysolutions.net/records/483/pcas-finland-oy/7b834bfa-b546-48d8-8742-08c28c804e1d

> FDA 483 for PCAS Finland Oy on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PCAS Finland Oy
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: PCAS Finland Oy, a manufacturer in Turku, Finland, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning procedures for equipment, deficient equipment qualifications failing to ensure proper performance, and insufficient certification records for classified production areas. These issues indicate a lack of control over manufacturing processes and environmental conditions.

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## Related Officers

- [Senior CSO, Investigator](https://www.globalkeysolutions.net/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

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

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