IanTech’s Reno, Nevada, facility was cited for failing to set up procedures for controlling and distributing finished devices.
Prior to shipping the finished product, the firm failed to establish a quality system that met regulatory requirements.
The firm also had a controlled environment room classified as an ISO Class 8 cleanroom that was used in the manufacturing of a sterile finished device.
When asked for qualification records, the firm provided validation result records but could not provide documented proof of validation activities. In addition, the controlled environment room’s qualification result records showed the cleanroom was qualified only after the finished device was manufactured.