III. During the FDA Inspection

  • Basic guidelines

  1.  Ensure that ALL members of the research team know that the FDA is in the facility. Inform other staff when you will be giving the inspector a tour of the facility.
  2. ***Limit idle business conversation by ALL staff.***
  3. During the inspection, the staff coordinating the inspection should oversee all inspector requests and take notes that will be written up at the conclusion of the inspection.
  4. Investigators are required to permit the FDA to inspect and copy any records pertaining to the investigation, including Protected Health Information (PHI).
    1. The UI prefers that research team members make the copies
    2. If the FDA does not require identifiers on the records, the research staff should redact the identifiers with black permanent marker
    3. If the FDA requests that identifiers remain on the records, the HIPAA Privacy Rule at 45 CFR 164.512(b)(1)(iii) permits this.
  5. If the FDA inspector insists on taking photographs or other video or audio recordings, take and retain duplicates at the same time.
  6. If the FDA inspector requests to take samples, ask for a receipt for the samples, and pull and retain identical samples at the same time.
  • Procedural steps

  1. Inspector arrival
    1. When the inspector arrives, s/he should check in at a specified location.
    2. Escort the inspector to the appropriate meeting room. The PI should be available when the inspector arrives or shortly thereafter.
    3. The inspector may ask for a tour of the facility.
    4. **The designated escort should stay with the inspector at all times.**
  2. Opening Meeting
    1. The inspector should present his/her credentials to the PI to verify that they are in order.
      1. Ask the inspector to see his/her credentials if s/he does not present them.
      2. Document all information from the inspector’s identification as no copies of the identification badges can be made.
    2. The inspector will present a Notice of Inspection (Form FDA 482) to the PI authorizing the inspection.
      1. This presentation officially begins the inspection.
      2. The inspector will explain the intended purpose and scope of the inspection.
      3. **If the team does not ask for the inspector’s credentials and/or the Form 482, the inspector may note this as a deficiency in his/her report.**
    3. The inspector will ask the PI to summarize and discuss the study identified for inspection and his/her responsibilities with respect to the study.
      1. The inspector may ask the PI for the list of his/her studies.
  3. Document inspection
    1. Standard procedure is for the inspector to request files for review, starting with the “general” study materials including:
      1. Regulatory documents binders.
      2. Signed informed consent forms.
      3. Sampling of specific patient records.
      4. Study finances (budget, contract, etc.) and personnel records are not included in the standard inspection, and should be excluded from the files shared with the inspector.
  4. Document photocopying
    1. **Provide only documents specifically requested by the inspector**
    2. Keep a “shadow binder” with a copy of every record/document that is provided to the inspector during the inspection.
    3. When making copies for inspectors:
      1. Remove subject identifiers from the copies given to the inspector, unless the FDA requests that identifiers remain (see #4, under "Basic Guidelines" above)
      2. Mark/stamp the copies that are given to the inspector “Confidential”.
      3. Mark/stamp the copies that are for the site’s FDA inspection file (shadow binder) “Copy”.
      4. Patient records may need to be obtained from the hospital or clinic to supplement or corroborate the research records.
    4. Copies are provided without charge to the FDA.
    5. Except for training/qualification records, the FDA inspectors ordinarily will not request to see personnel records, financial records, and records of internal inspections (Section 704(a) FDC Act).
  • Principal Investigator availability during the inspection

  1. The PI should plan on being available each day to talk with the inspector, either in person or by phone, in order to answer any questions that may arise.
  2. These arrangements are usually discussed during the opening meeting.
  • Study staff response to inspector’s questions

  1. During the inspection, the person coordinating the inspection should keep an exhibit log that includes a list of ALL questions asked by the inspector.
  2. The inspector will ask the PI, study coordinator and members of the study team questions in order to:
    1. Assess consistency and accuracy in response.
    2. Compare knowledge and practice of study procedures.
    3. Assess for PI oversight, involvement, and knowledge of day-to- day, routine activities.
    4. For questions frequently asked by the FDA inspectors, see Appendix 2.
  3. The inspector may ask to review the research team’s standard operating procedures (SOPs) or documentation of team training. If applicable:
    1. Provide documentation of research team’s meeting minutes.
    2. Provide copies of power point presentations/other training or certificates that are available.
  4. Answer questions with the following tips in mind:
    1. Listen to the question carefully. If you do not understand the question, ask the inspector to explain. Do not attempt to interpret the meaning of unclear questions being asked.
    2. Be truthful – answer the question that was asked in an honest manner.
    3. Be concise –use “yes” or “no” when sufficient, and stop when the question is fully answered and wait for the next question.
    4. Answer only the question that is asked.
    5. DO NOT speculate or guess – if you do not know the answer to a question, do not be afraid to tell the inspector you don’t know. If a question is outside your area of responsibility, say so and write down the question and refer it to the correct person.
    6. Do not bring documents to an interview unless requested to do so.
    7. DO NOT argue.
  • Signatures on Affidavits

  1. DO NOT sign any affidavits provided to you by the inspector.
  2. If the inspector presents an affidavit for signature, politely decline to sign and tell the inspector that you must first consult with the University’s Office of the General Counsel.
  • Exit Interview

  1. Prior to the exit interview, study staff should notify the Privacy Officer and Pharmacy Administrator in case these individuals want to attend the visit.
  2. The inspector will usually hold a “close-out” visit at the conclusion of the inspection.
  3. The inspector will discuss findings and notify the PI if deficiencies were found. This is an opportunity for the PI to provide information and clarify any questions or concerns raised during the inspection.
  4. If serious deficiencies have been found during the inspection, a written Inspectional Observations (Form FDA 483) will be issued, which lists the deficiencies.
  5. If no deficiencies are found, or the inspector has comments that s/he believes are not serious enough to warrant a Form FDA 483, no form will be issued.
  6. Study staff should:
    1. Document the interview, specifically noting observations, comments, and any commitments discussed.
    2. Seek to correct any errors in the findings.
    3. Email the IRB Compliance Specialist a copy of the Exit Interview summary at irb-monitors@uiowa.edu.