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Volume III - 5.4 Establishment Inspection Reports

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-05

VERSION NO.:1.5

Section 5 - Analysts on Inspection

EFFECTIVE DATE: 10/01/2003REVISED: 01-30-13

Upon completion of an inspection, an Establishment Inspection Report (EIR) is written which details inspectional findings. Because analysts may work independently of investigators during a team inspection, the analyst will submit a written report which is appended to the investigator's report. Excellent communication between the analyst and the investigator is the key during this type of inspection. There are some situations when the analyst and investigator are working so closely together that a separate report may not be needed, for example, the inspection of a contract laboratory. In this case, the analyst and investigator work out the details of how the report is to be written. All reports are prepared as stand-alone documents outside of FACTS. The establishment Inspection Report (EIR) is to: 

  • Be factual, objective, and free of unsupportable conclusions.
  • Be concise while covering all aspects of the inspection.
  • Not include opinions about administrative or regulatory follow-up.
  • Be written in the first person.
  • Be signed by all FDA and commissioned personnel participating in the inspection.  See IOM section 502.4 when more than one FDA or commissioned person participated in the inspection.

For an inspection that does not fall under the auspices of TurboEIR, the analyst portion may consist of several sections depending on the scope and the length of the inspection. The IOM gives detailed guidance about the content of the EIR under section 5.10 – Narrative Report and 5.5.8- Drug Inspection Reports.

http://www.fda.gov/ICECI/Inspections/IOM/ucm123287.htm

  • Analytical Narrative
  • Objectionable Conditions
  • Discussion with Management
  • Exhibits

The narrative section details what was covered during the inspection (e.g. Samples/Batch review, Testing/Laboratory Operations, Laboratory Equipment Calibration/Qualification, Standards/Controls/Media/Reagents, Method Validation, OOS/Failure Investigations etc). Depending on the scope, length of the inspection and significance of the finding, the analyst and the investigator may choose to include subheadings in order to clarify the report. The Objectionable findings/conditions section includes a detailed account of each objectionable condition (verbal and/or listed on the FDA 483) including a clear description of each, its impact on the product, batches or lots involved, and any relationship to other products or processes. Identify the responsible party for each violation. Report the discussion of all objectionable conditions from the daily inspection review and the discussion with management at the conclusion of the inspection. The "Discussion with Management" section of the report records management's response to objectionable conditions which are discussed during the exit interview. It also includes the names and titles of each person at exit interview. The investigator and analyst need to coordinate who writes this section and how it is written.