Date Published:
Wed, 03/17/2010Warning letter citing delayed entry of adverse event data into the eCRF.
Regulatory Actions
3CPM company, 3/10
Date Published:
Thu, 03/25/2010Warning Letter citing multiple validation and change control issues for both product and quality systems.
Oympus Temmo Biomaterials, 2/10
Date Published:
Thu, 02/25/2010Warning Letter citation referring to failure to validate CAPA analysis software
Interacoustics A/S, 12/09
Date Published:
Thu, 12/10/2009Failure to validate software changes prior to implementation
Ohm Laboratories, 8/09
Date Published:
Wed, 08/12/2009483 identifying multiple deficiencies in security, back-ups, and password protection for laboratory systems.
Toledo MD, 3/10
Date Published:
Thu, 03/11/2010Warning letter highlighting multiple discrepancies between source documents and electronic records.
Cardiac Science, 2/10
Date Published:
Fri, 02/05/2010Warning Letter citation highlighting multiple CAPA and validation issues for device software.
Xian Libang Pharmaceutical, 1/10
Date Published:
Thu, 01/28/2010Warning Letter requesting details of the configuration, qualification approach, and procedures for a system referenced in an earlier audit response.
Ohm Laboratories, 12/09
Date Published:
Mon, 12/21/2009Warning Letter highlighting several issues potentially impacting the integrity of laboratory data.
Crothal Healthcare, 12/09
Warning Letter noting that company did not provide evidence of system validation or usage procedures.
