Benjamin Franklin said, “By failing to prepare, you are preparing to fail.” Prepare for your FDA inspections with Establish Inspection Reports (EIR). An EIR is the full report of an FDA inspection written by the investigators. Among the features identified in the report are:
- a physical description of the site(s) inspected,
- business history and previous FDA inspection history,
- confirmation that the firm engages in inter-state commerce thereby establishing FDA’s authority over the firm,
- discussion of the areas and documents evaluated often including conclusions,
- a list of individuals and their titles with whom the inspectors spoke
- the form 483 identifying the exhibits (documents generally) which support the observation
- additional information including the firm’s response, if any, made at the closing meeting.
These reports are expected to be available thirty days after the inspection though this often takes longer depending on the district or the specific inspection. Unlike the form-483 issued by the inspectors at the close of the inspection, the EIR is reviewed and approved by supervisory staff because it includes the assignment of inspection outcome and must be requested after the close of the inspection. Firms should request their EIR from the district office or the office that conducted the inspection.
Five of the features I look for in an EIR include (And what do do with them):
- 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. For example, your FDA readiness team could evaluate whether any of the documents are those that have not routinely been requested during inspections and prepare those documents accordingly.
- 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. Address similar or potential problems in your firm accordingly.
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. The practices and procedures that FDA determined did not meet the seriousness to be cited on the form-483, but were nevertheless mentioned at the inspection closeout, provide a strong suggestion that FDA expects those to be remediated by the time of the next inspection. Benjamin Franklin also said, “An ounce of prevention is worth a pound of cure”.
Written by Barbara Unger, Editor-in-Chief of GMP Regulatory Intelligence and GMP Quality Expert