Date Published:
Fri, 05/29/2009Warning Letter citing two failures to validate that systems were suitable for their intended purpose.
Warning Letters
Hill Dermaceuticals, 4/09
Date Published:
Mon, 04/27/2009Warning Letter noting failure to verify spreadsheet calculations used to release products.
Jones MD, 7/09
Date Published:
Wed, 07/01/2009Warning Letter requesting procedures and training records regarding an electronic system for inventory and shipping records.
Zosa MD, 6/09
Date Published:
Tue, 06/16/2009Warning Letter noting failure to generate or retain documentation to corroborate data in the electronic system.
Inditherm Medical, 6/09
Date Published:
Wed, 06/10/2009Warning Letter citing failure to approve software changes prior to implementation.
Apotex, 6/09
Date Published:
Thu, 06/25/2009Warning Letter requesting additional information on the company's use electronic means to replace physical label copies in the master batch record.
Storz Endoskop, 5/09
Date Published:
Mon, 05/18/2009Warning Letter citation noting failure to adequately address use of an electronic complaint handing system in an SOP.
Advanced Neuromodulation Systems, 6/09
Date Published:
Fri, 06/26/2009Warning Letter citing inadequate device software validation, CAPA investigation, and corrective action.
Water and Power Technologies, 5/09
Date Published:
Wed, 05/20/2009Warning Letter noting failure to validate calculations.
Lupin Limited, 5/09
Date Published:
Thu, 05/07/2009Warning Letter noting issues with spreadsheet data integrity and SAP inventory status functions.
