Some common deficiencies observed by FDA investigators include:
Failure to follow the investigational plan and signed investigator statement/agreement (e.g., failure to conduct or supervise the study in accordance with the relevant, current protocol(s)). See 21 CFR 312.60 and 812.110(b).
Protocol deviations (e.g., failure to appropriately document and report any medically necessary protocol deviations). See 21 CFR 312.66 and 812.150(a)(4).
Inadequate record keeping. See 21 CFR 312.62 and 812.140(a).
Inadequate accountability for the investigational product. See 21 CFR 312.62(a) and 812.140(a)(2).
Inadequate subject protection, including informed consent issues. See 21 CFR part 50, 312.60, and 812.100.