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.
Importantly, the CAPA procedures didn’t ensure that information that related to quality issues or nonconforming product was disseminated to the quality unit.
Inspectors discovered the firm also had not validated its computer software. The firm had used the software since 2005 for documenting and monitoring nonconformities with customer complaints, suppliers, internal and external audits; however, it didn’t provide validation documentation.
The agency also took issue with the firm’s failure to establish procedures to ensure that device history records for each batch of product was made according to the device master record (DMR) as required by 21 CFR 820.184, the warning letter says.
For example, the firm had not maintained copies of primary identification labels used in the DHRs, and some DHRs didn’t have identification information for inspection or test equipment used for the finished product acceptance activities.
The agency warned Eolane Vailhauques that premarket approval applications for Class III devices would not be approved until the violations have been corrected.
Eolane Vailhauques Managing Director Steve Bureau told IDDM that “all the actions are settled and were sent to the FDA.”