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

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.