Date Published:
Wed, 04/23/2008Warning Letter citation regarding inadequate handling of software complaints.
Regulatory Actions
Philips Medical Systems, 4/08
Date Published:
Tue, 04/01/2008Warning Letter containing numerous examples of issues regarding device software validation and complaint handling.
Stratec Medizintechnik, 9/08
Date Published:
Wed, 09/10/2008Warning Letter citation referring to computer generated records which do not contain the signature of the individual who performed the test.
Whitney Labs, 9/08
Date Published:
Tue, 09/02/2008Warning Letter citation noting failure to validate automation software.
IBA Molecular, 10/08
Date Published:
Fri, 10/24/2008Failure to investigate an unplanned deviation regarding a computer failure.
BioMedix Vascular Solutions, 10/08
Date Published:
Thu, 10/16/2008Warning letter referring to failure to investigate complaints regarding incorrect data storage in devices
Steris, 9/08
Date Published:
Thu, 09/25/2008Warning Letter citation concerning failure to adequately control migration of unapproved software revisions and failure to take preventive action to prevent reoccurrence.
Fall Prevention Technologies, 8/08
Date Published:
Wed, 08/27/2008Warning Letter including examples of validation and CAPA deficiencies for device software as well as a record protection deficiency for a complaints program.
Sandoz, 8/08
Date Published:
Tue, 08/12/2008Warning Letter citation noting lack of data protection from tampering due to inadequte security controls and audit trails.
Mavidon Medical Products, 8/08
Date Published:
Fri, 08/08/2008Warining letter noting failure to validate system prior to use in manufacturing and product release.
