Eagle Diagnostics, Inc. – FDA Warning Letter, Nov 1, 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. These products are medical devices under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. The inspection revealed these devices are adulterated per section 501(h) of the Act, as 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 identified in the FDA-483 include: 1. Failure to establish and maintain quality audit procedures and conduct audits (21 CFR § 820.22), with no internal quality audits since January 20, 2006. 2. Failure to establish and maintain device master records (DMRs) (21 CFR § 820.181), lacking DMRs for products manufactured/repacked since 2005. 3. Failure to establish and maintain device history records (DHRs) (21 CFR § 820.184), with no DHRs maintained for products manufactured/repacked between September 2008 and October 2010. 4. Failure to