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

Source: https://www.keypedia.com/records/483/rechon-life-science-ab/e1159319-cade-426b-b53e-0e5f1f6a374c

> 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 Inspections and Investigations
- Summary: An FDA inspection of Rechon Life Science AB in Limhamn, Sweden, revealed significant deficiencies in aseptic processing, environmental monitoring, and contamination control. The firm failed to establish scientifically justified contamination recovery limits, ensure proper operator qualification for aseptic interventions, and adequately investigate recurring discrepancies like abnormal flora and leak test failures. These issues indicate a lack of robust quality systems necessary for sterile drug product manufacturing.

## Related Documents

- [483 - 2023-03-17](https://www.keypedia.com/records/483/rechon-life-science-ab/a7301184-4d67-4fbc-b22a-7e0804189aa2)
- [483 - 2024-09-06](https://www.keypedia.com/records/483/rechon-life-science-ab/36f4eea5-fa8b-4cb8-8f47-b7a20c9ecab9)
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- [WARNING_LETTER - 2024-09-06](https://www.keypedia.com/records/warning_letter/rechon-life-science-ab/ec7b8f99-2090-44b2-b048-fe367628faae)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8