# FDA 483 - KYMOS Pharma Services S.L - July 18, 2017

Source: https://www.keypedia.com/records/483/kymos-pharma-services-sl/126aa998-8273-4f6d-b21f-1cbf3abc1489

> FDA 483 for KYMOS Pharma Services S.L on July 18, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KYMOS Pharma Services S.L
- Inspection Date: 2017-07-18
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: KYMOS Pharma Services S.L, a contract control testing laboratory in Cerdanyola del Valles, Spain, received an FDA Form 483 with eight observations. The inspection revealed significant issues primarily related to data integrity, laboratory controls, and investigation practices, including backdating investigations, lack of audit trail reviews, unvalidated spreadsheets, and inadequate computer system controls. These deficiencies indicate a systemic failure to adhere to good manufacturing practices for drug product testing and release.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/toyin-b-oladimeji/0aff4ab4-a1ff-4394-a32d-747bdc5f248b)

Company: https://www.keypedia.com/companies/kymos-pharma-services-sl/b9a15513-d9c4-44de-9766-3331b7b6ab3b

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