About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

The FDA investigator and clinical investigator will have a meeting and the FDA investigator will ask questions and review any findings during the inspection. If there are any deficiencies, the FDA investigator will issue a written Form FDA 483 (Inspectional Observations; 483) to the clinical investigator or his/her representative. The clinical investigator may respond to the 483 observations orally during the exit interview and/or respond in writing after the inspection. Following the above process, 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. A Warning Letter is issued for violations of regulatory significance.
  4. A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) that 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 agency may issue a Notice of Opportunity for Hearing (NOOH).

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