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

Source: https://www.globalkeysolutions.net/records/483/pcas-finland-oy/d2b356c4-7b1c-4bd8-aafc-d3b75e123c49

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

---

## Details

- Record Type: 483
- Company Name: PCAS Finland Oy
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of PCAS Finland Oy, an API manufacturer in Turku, Finland, revealed significant deficiencies in quality control and facility maintenance. The firm failed to investigate unknown impurities in its Active Pharmaceutical Ingredient (API) using an in-house analytical method and lacked established maintenance procedures for critical manufacturing equipment. Additionally, the inspection found poor repair and maintenance of manufacturing spaces and equipment in bioburden-controlled areas, including holes in exhaust vents and compromised air intake vents.

## Related Documents

- [483 - 2019-09-13](https://www.globalkeysolutions.net/records/483/pcas-finland-oy/7b834bfa-b546-48d8-8742-08c28c804e1d)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321