What are your top concerns about FDA inspection? 

1. The first step to address concerns is to gain an understanding of how to prepare for an FDA inspection. By developing an inspection readiness plan, you not only reduce concerns but also infuse inspector confidence in the quality system.


2. Develop a standard operating procedure for managing the inspections. The 'Managing Inspections' SOP must:

  • Develop an inspection readiness team that consists of members from the quality organization and cross-functional groups.
  • Predetermine/ allocate work space rooms for inspectors and audit support.
  • Predetermine the SMEs and presenters of protocols deviations will be.
  • It is good to have mock up sessions and presentations defending SOPs, deviations, trend reports, and validations.
  • Organize all Regulatory Files by general heading arranged in chronological order. 
  • Well-written summaries too go a long way in simplifying the inspection. 
  • Develop a strategy to justify decisions made.


3. During the inspection/ Arrival

  • Record the name, date/time.
  • Notify the quality head and the operations head and their backups about the arrival of the regulatory inspectors.
  • In the opening meeting, obtain information about what type of inspection will be conducted.


 4. Postapproval/ Surveillance/ For cause or directed

  • A brief introductory presentation showing the organizational chart, headcount, hours of operation and facility layout can be made on the first day. 

  • Also, inspection will include a facility tour and that is generally on the first day.

  • The inspector will make a note of the equipment numbers and personal names during the tour.

  • Each document request should be logged and sent to the audit support room. 

  • Ensure that the inspector does not have to repeatedly ask for the requested documents

  • Be honest in answering questions. 

  • Take corrective actions if possible, commit only to what can be delivered.

  • Get debriefed of the day's observations from the inspector at the end of each day.

  • When documents are copied for inspectors, make a copy to retain or identify the copied document by maintaining an inspection record log.

  • Stamp each copy you proved as "Confidential".


 5. Exit Interview

  • The Inspector will generally hold an exit interview at the end of the inspection.

  • If serious deficiencies have been identified during the inspection, the regional office will send and Inspectional Observations form 483 listing the deficiencies.


 6. Follow-up

  • If a 483 is issued, make a written response by including the specifics.
  • Provide a reasonable timeline for the correction.
  • Address every finding point by point.
  • Send the reply within two weeks.
  • Maintain a copy of the final signed response.


RESOURCE PERSON: BARBARA PIROLA