FDA 483 - Busse Hospital Disposables, Inc. - April 13, 2018

An FDA inspection of Buerer Hospital Disposables, Inc. in Hauppauge, NY, a manufacturer of hospital disposables, revealed two significant issues. The firm failed to adequately establish procedures for monitoring and controlling process parameters for a validated process, specifically noting identical Installation Qualification and Operation Qualification documents for a towel machine. Additionally, the firm did not adequately establish requirements for suppliers and contractors, as evidenced by a failure to open a CAPA for multiple vendor non-conformances related to syringes.