FDA WARNING_LETTER - Genetics & IVF Institute IRB - October 01, 2009

The FDA issued a Warning Letter to Genetics & IVF Institute's IRB following an inspection from September 24 to October 1, 2009, which revealed serious violations of 21 CFR Part 56 (Institutional Review Boards). The inspection aimed to ensure compliance with federal regulations for IRBs reviewing device investigations (21 CFR Parts 50, 56, and 812) and to protect human subjects.

Key violations include: 1. **Failure to conduct continuing review:** No documentation of continuing review for a study from October 2002 to February 2005, despite it being ongoing. (21 CFR 56.109(f), 56.115(a)(3)) 2. **Inadequate meeting minutes:** Minutes from May 2000 to July 2009 inconsistently listed attendees and lacked voting details (for, against, abstaining). Approval dates in a June 2009 letter did not correspond with actual meeting dates, and a program's review was delayed by three months. (21 CFR 56.115(a)(2)) 3. **Failure to advise members of expedited approvals:** No documentation that IRB members were notified of expedited approvals for status reports in 2002, 2003, and 2004. (21 CFR