FDA WARNING_LETTER - Eagle Diagnostics, Inc - November 01, 2010

On October 18 - November 1, 2010, an FDA inspection of Eagle Diagnostics, Inc. found the firm manufactures and repacks in vitro diagnostic reagents for export, which are medical devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Significant violations cited in the FDA-483 include: 1. Failure to establish and maintain quality audit procedures and conduct audits (21 CFR § 820.22), specifically no internal quality audits since January 20, 2006. 2. Failure to establish and maintain device master records (DMRs) (21 CFR § 820.181), with no DMRs for in vitro diagnostic reagents manufactured/repacked since 2005. 3. Failure to establish and maintain device history records (DHRs) (21 CFR § 820.184), with no DHRs for products manufactured/repacked between September 2008 and October 2010. 4. Failure to establish and maintain procedures for routine equipment calibration, inspection, checking