# FDA 483 - Rechon Life Science AB - March 17, 2023

Source: https://www.globalkeysolutions.net/records/483/rechon-life-science-ab/a7301184-4d67-4fbc-b22a-7e0804189aa2

> FDA 483 for Rechon Life Science AB on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rechon Life Science AB
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Rechon Life Science AB, a human drug manufacturer in Limhamn, Sweden, was cited for significant deficiencies in its aseptic processing, quality control, and investigation systems. The inspection revealed issues with environmental monitoring, microbiological contamination prevention, visual inspection processes, and the thorough review of unexplained discrepancies. These findings indicate a lack of robust controls to ensure the sterility and quality of drug products.

## Related Documents

- [483 - 2024-09-06](https://www.globalkeysolutions.net/records/483/rechon-life-science-ab/23e6f4c7-90bc-4c26-9550-fd7a3b364fa7)
- [WARNING_LETTER - 2024-09-06](https://www.globalkeysolutions.net/records/warning_letter/rechon-life-science-ab/ec7b8f99-2090-44b2-b048-fe367628faae)
- [483 - 2024-09-06](https://www.globalkeysolutions.net/records/483/rechon-life-science-ab/ccd7dd5f-15da-4468-8ee0-cf8f066be75d)

## Related Officers

- [Monica E. Murie](https://www.globalkeysolutions.net/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.globalkeysolutions.net/companies/rechon-life-science-ab/ce84eed4-ada6-40a0-9005-2c2d6bbd729d

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