FREQUENTLY Asked Questions

What happens after an IRB inspection?

Just like all other FDA inspections, an exit interview will be conducted. The FDA inspector, responsible institutional individual, and IRB representatives will attend the exit interview where they will discuss any findings from the inspection. If any deficiencies are found, the FDA investigator will issue a written Form FDA 483 to the most responsible IRB representative. The IRB may respond to the 483 observations verbally during the exit interview and/or respond in writing after the inspection. If the IRB or responsible institution 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 personnel who conducted the IRB inspection prepare a written Establishment Inspection Report (EIR). The EIR, 483 (if issued), copies of any materials collected during the inspection, and any IRB response are forwarded to the appropriate FDA Center for further evaluation. After this review, one of the following types of letters is typically sent from the Center to the IRB chairperson or other responsible institutional official:

  1. A letter that generally states that FDA observed no significant deviations from the 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 for which voluntary corrective action is sufficient. Occasionally, such letters request a response from the IRB.
  3. A Warning Letter that identifies serious deviations from applicable statutes and regulations. A Warning Letter generally requests prompt correction by the IRB and a formal written response to the Agency.
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