FDA WARNING_LETTER - Brookwood Medical Center - November 19, 2009

On April 22, 2010, the FDA issued a Warning Letter to Brookwood Medical Center following an inspection of its Institutional Review Board (IRB) from November 9-19, 2009. The inspection, conducted by Ms. Patricia S. Smith, aimed to assess compliance with 21 CFR Parts 50 and 56 regarding human subject protection in clinical investigations.

The FDA concluded the IRB failed to adhere to statutory requirements and FDA regulations. A Form FDA 483 was issued, and while Brookwood Medical Center submitted a response on January 6, 2010, it was not considered due to being received more than 15 business days after the 483 issuance. This response will be evaluated as a direct response to the Warning Letter.

Key violations include: 1. **Failure to follow written procedures for continuing review of research [21 CFR 56.108(a)(1)]**: Multiple instances of lapsed IRB approval were found for protocols (b)(4), (b)(4), and (b)(4), with lapses ranging from one month to ten months. This was a repeat observation from a February 2003 inspection. 2. **Failure to follow written procedures for approving changes in research [21 CFR 56.108(a)(4)]**: Protocol changes for (b)(4) (e.