Understand EIR: 5 FEATURES TO LOOK FOR IN AN EIR.
Context – The EIR provides more context about the conduct of the inspection than does the form-483 alone. You can often determine how and why the investigators reached specific conclusions and understand the full scope of documents and practices they evaluated. This insight into the investigator’s inspection process can inform inspection readiness activities at your firm.
Documents Collected – The EIR lists the documents that were collected and reviewed. Determine whether any of the documents reviewed are different than the type evaluated in the past and prepare the necessary documents.
Potential Objectionable Conditions – situations and practices that need to be corrected prior to the next inspection. If the processes or procedures are not corrected by the next inspection, expect them to be cited on the next form-483. Correct similar problems in your firm before your next inspection.
Samples Collected – The EIR identifies which if any samples were collected, and perhaps why they were collected. If the list is extensive, this can suggest a potential problem. Correct similar problems in your firm accordingly.
Enforcement Actions – The EIR will generally suggest whether additional enforcement actions are recommended included warning letters or import alerts and whether a follow up inspection is necessary.
In conclusion, an EIR provides a wealth of information regarding the site, conduct, and outcome of an inspection. It is particularly useful for firms to understand what areas the FDA focuses on and how the FDA reviews documents.
