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FDA Warning Letter Hits US Lab On Data Integrity, Password Sharing

 
• By Joanne S. Eglovitch

Data integrity lapses raised in FDA warning letter to California analytical testing lab shows that such issues are not confined to Asia and that FDA will, in fact, challenge US facilities to show they are managing their quality data properly.

FDA Aug. 2 issued a data integrity-focused warning letter to a California testing laboratory after it had failed for more than three years to turn on audit trails in testing equipment and give analysts their own passwords.

The warning letter, issued by the agency's Los Angeles District Office, proves that US facilities are not exempt from the relentless focus on data integrity issues that the agency has...

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