# FDA 483 - Rechon Life Science AB - September 06, 2024

Source: https://www.keypedia.com/records/483/rechon-life-science-ab/23e6f4c7-90bc-4c26-9550-fd7a3b364fa7

> FDA 483 for Rechon Life Science AB on September 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rechon Life Science AB
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Rechon Life Science AB, a sterile drug products manufacturer in Limhamn, Sweden, was cited for significant deficiencies during an FDA inspection. The observations highlight inadequate aseptic processing controls, including issues with personnel flow, environmental monitoring, and cleaning procedures, leading to potential microbial contamination. Additionally, the firm failed to thoroughly investigate out-of-specification and out-of-trend laboratory results, indicating a lack of robust quality control.

## Related Documents

- [483 - 2023-03-17](https://www.keypedia.com/records/483/rechon-life-science-ab/a7301184-4d67-4fbc-b22a-7e0804189aa2)
- [WARNING_LETTER - 2024-09-06](https://www.keypedia.com/records/warning_letter/rechon-life-science-ab/ec7b8f99-2090-44b2-b048-fe367628faae)
- [483 - 2024-09-06](https://www.keypedia.com/records/483/rechon-life-science-ab/ccd7dd5f-15da-4468-8ee0-cf8f066be75d)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

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