At the end of an inspection, the FDA investigator conducts an exit interview with the clinical investigator or his/her representative. At this interview, the FDA investigator who conducted the inspection reviews and discusses the findings from the inspection and, if deficiencies were found, issues a written Form FDA 483 (Inspectional Observations; 483) to the clinical investigator or his/her representative. The 483 describes any inspectional observations that, in the opinion of the FDA investigator conducting the inspection, represent deviations from applicable statutes and regulations.
Some common deficiencies that have been observed by FDA investigators during a clinical investigator inspection 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 recordkeeping. 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.
The clinical investigator may respond to the 483 observations orally during the exit interview and/or respond in writing after the inspection. If the clinical investigator chooses to respond in writing to the deficiencies listed on the 483, the response should be directed to the FDA District Office listed in the upper left corner of the 483.
Following the inspection, the FDA investigator who conducted the inspection prepares a written Establishment Inspection Report (EIR). The EIR, Form FDA 483 (if issued), copies of any materials collected during the inspection, and any clinical investigator response that has been received by the District Office are forwarded to the appropriate FDA Center for further evaluation and final classification of the inspection outcome. After this review, one of the following types of letters is typically sent from the appropriate FDA Center to the clinical investigator:
(1) A letter that generally states that FDA observed basic compliance with pertinent regulations. Note that a letter is not always sent when FDA observes no significant deviations.
(2) An Informational or Untitled Letter that identifies deviations from statutes and regulations that do not meet the threshold of regulatory significance for a Warning Letter. Generally, such letters may request a written response from the clinical investigator.
(3) A Warning Letter that identifies serious deviations from applicable statutes and regulations.
(4) A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE). FDA may initiate a process to disqualify the clinical investigator from receiving investigational new drugs and/or biologics if disqualified under part 312, or investigational devices if disqualified under part 812, if the investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or has deliberately or repeatedly submitted false information to the sponsor or FDA in any required report. See 21 CFR 312.70 and 812.119. The NIDPOE identifies alleged violations and provides the investigator with an opportunity to explain the matter at an informal conference or in writing. If, in response to the NIDPOE, the investigator provides an explanation that is accepted by the agency and the disqualification is not warranted, alternatives such as a detailed corrective action plan may be considered. If the investigator’s explanation is not accepted by the agency, the FDA may issue a Notice of Opportunity for Hearing (NOOH) under 21 CFR part 16.
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