FDA WARNING_LETTER - Genetics & IVF Institute - June 30, 2009

This FDA Warning Letter, dated November 20, 2009, addresses objectionable conditions observed during an FDA inspection of Genetics & IVF Institute from June 23-30, 2009. The inspection aimed to determine compliance with federal regulations for the clinical study of the investigational device (b)(4).

The letter identifies serious violations of 21 CFR Part 812 - Investigational Device Exemptions. Key violations include:

1. **Failure to ensure adequate monitoring and secure investigator compliance (21 CFR 812.40, 21 CFR 812.46(a)):** The sponsor failed to monitor the investigation according to their written procedures, specifically regarding monitoring visit frequency at two clinical sites (b)(4) and (b)(4). For instance, the (b)(4) site had no monitoring visits in 2000, 2001, and 2008, and only one visit per year for 2004-2007. The (b)(4) site had no visits in 2004-2005 and only one per year for 2006-2008. The sponsor also failed to secure compliance or terminate the investigation despite repeated notifications (as early as December 31, 2007) of the principal investigator's noncompliance with informed consent documentation