French Devicemaker Lands Warning Letter for Validation, CAPA Failures

Failure to validate equipment and computer software, and not establishing adequate procedures for implementing corrective and preventive actions, landed French devicemaker Eolane Vailhauques an FDA warning letter.

The Feb. 4 letter cites the firm for failing to validate its galvanic skin response measurement device. During a Sept. 18, 2015 inspection at the Vailhauques facility, inspectors noted that the firm had not established procedures for monitoring and controlling the parameters of validated processes.

Moreover, the firm’s CAPA procedures didn’t include requirements for verifying the corrective actions didn’t adversely affect the finished device. The CAPA procedures also didn’t include requirements for making changes in methods and procedures needed to correct or prevent quality problems.