Failure to validate the finished device testing software for the ProNeb and Duraneb 2000 compressors and complaint handling software according to established protocols; failure to establish written procedures for monitoring and control of process parameters; failure to establish written procedures and to develop specifications for the contract manufacturer; and failure to establish final acceptance procedures.
1. Failure to validate the finished device testing software for the ProNeb and DuraNeb 2000 compressors and complaint handling software according to established protocols.
