FDA WARNING_LETTER - Nanosphere, Inc. - April 04, 2014

The FDA conducted an inspection of Nanosphere, Inc., a manufacturer of Class II in vitro diagnostic assays, from March 26 to April 4, 2014. The inspection revealed that the firm's devices, including the Verigene® Processor SP System, are adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) Regulation (21 CFR Part 820) and misbranded under 21 U.S.C. 353(t)(2).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(1))**: The CAPA procedure (QASOP-032) lacked detailed instructions for initiating investigations and was not followed regarding the use of audit findings as a data source. For example, "maximum high risk" issues from a November 2013 external audit did not lead to immediate CAPA initiation, with CAPAs 14-003 and 14-013 opened in February 2014. QRB meetings did not discuss audit findings until January 2014, despite awareness in November 2013. The firm's responses were deemed inadequate as they did not address the lack of detail for immediate investigations or how audit findings are analyzed.