# FDA 483 - Pharmaloop, S.L. - April 16, 2024

Source: https://www.keypedia.com/records/483/pharmaloop-sl/c65886c6-337e-4fc0-8f55-a3bc8a551b25

> FDA 483 for Pharmaloop, S.L. on April 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaloop, S.L.
- Inspection Date: 2024-04-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pharmaloop, S.L. in Alcala de Henares, Spain, was inspected by the FDA from April 8-16, 2024, and received a Form 483 with two observations. The inspection revealed significant issues with preventing microbiological contamination in sterile drug products, including problems with environmental monitoring and aseptic filling processes. Additionally, the firm failed to adequately test raw materials used in drug product manufacturing.

## Related Officers

- [Lori B. Wikstrom](https://www.keypedia.com/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)

Company: https://www.keypedia.com/companies/pharmaloop-sl/919575db-21db-43ae-a599-12a19a0f95e2

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