303 FDA Inspection Preparation and Procedures

Purpose

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Procedures

The Principal Investigator (PI) or designated personnel must adhere to the following procedures before and after implementing a study protocol:

1. Notice of FDA Inspection

• The individual (PI, Sponsor, Research Staff) contacted by the FDA regarding an inspection must immediately inform the CTRU Director. The Director will then notify the Office of Research Compliance, the PI, and the Sponsor about the scheduled or impromptu inspection.
  • All staff should be briefed on the procedures for welcoming an FDA Inspector before the inspector arrives at the site.
  • If available, a private conference room will be reserved for the inspector to conduct their review.
  • A host, preferably the Study Coordinator or Project Manager, will be designated to facilitate the audit and communicate directly with the FDA Inspector. If possible, this should be done before the audit date. A back-up host should also be identified in case the primary host is unavailable during the audit.
  • The host will be responsible for documenting all pertinent activities related to the FDA inspection once it has been confirmed.

2. Arrival of Inspector

• The Principal Investigator and/or designee will greet the FDA Inspector and verify their identification and credentials.
• The inspector will provide an FDA Form 482 (Notice of Inspection) and will then be asked to sign the Site Visitor’s Log.
• The host will record the inspector’s badge number and obtain a copy of the FDA Form 482.
• The Principal Investigator and/or designee will ensure that all requested study-related documents are available.
• The Principal Investigator and other relevant staff will be present during the FDA inspection. It is strongly recommended that a representative from the IRB also be present if possible. Staff members should answer the FDA Inspector's questions directly and concisely, without volunteering unsolicited information or documentation.
• The designated host will facilitate the audit and maintain communication with the FDA Inspector throughout the inspection.

3. Conduct of Inspection

• The designated host will:
  • Determine the purpose of the inspection.
  • Determine the expected duration of the inspection.
  • Ensure that information and staff are available as needed.
  • Provide the inspector with the requested documents.
  • Accompany the inspector during tours and interviews.
  • Maintain a list of questions asked by the inspector that require consultation.
  • Keep a record of documents requested.
  • Keep a record of documents copied.
  • Keep a record of staff interviewed.
  • Assist the inspector as needed.
  • Arrange for a debriefing at the conclusion of the audit.
  • Arrange follow-up, if required.

4. Notice of Findings

• At the conclusion of the inspection, the FDA Investigator may provide an FDA Form 483 (Inspection Observation), which lists observed compliance issues.
• These issues should be discussed during the close-out meeting or exit interview.
• If no issues are identified, then no FDA Form 483 will be issued.
• If significant issues are listed in the FDA Form 483, a Warning Letter may be issued following the inspection.

5. Follow-up

• If the FDA Inspector provides the Principal Investigator with a response to the audit in the form of an FDA Form 483 (Inspection Observation), the Principal Investigator, in consultation with the CTRU Director, will prepare a written response to any observations noted on this form and send the response to the FDA within the appropriate timeframe. The written response will include:
  • Adequate responses to each observation, including explanations of the steps taken or planned to remedy the observation and prevent future occurrences. Timelines for completion will be included.
  • Responses that are factual and cooperative in tone.
• It is important to note any findings that have been addressed during the inspection.
• A copy of the FDA Form 483 and the response to the observations will be sent to the sponsor representative of the research, if applicable.

References: None

Attachments: None

Appendices: None

Approver: Director, CTRU and Clinical Partnerships