Pre-FDA Audit Inspection Day Checklist

Put together an Inspection Team that will be responsible for dealing with the inspection when the FDA is on the premises. The inspection team should consist of:

Responsible Person — Select a high-level officer or manager, someone with ultimate responsibility for the company’s compliance. This person could be as high level as the CEO or COO / PRESIDENT. In some instances, someone like a General Manager might be appropriate.

Inspection Escort — Select a management level employee (e.g., Quality Head or General Manager, Operations Manager) who is familiar with the everyday operations of the company. He or she needs to be a good tour guide, know where everything is, and be able to answer general questions about the day-to-day operations in the facility.

Subject Matter Experts — Select team members who are knowledgeable and competent enough to answer very specific questions that the FDA may have. For example, these questions may address intake of products, raw materials; manufacturing/GMPs; hazard analysis and preventative controls; distribution; product traceability/recalls, and labeling. These SMEs most likely would not be with the inspector throughout the duration of the inspection, but rather would be available when needed for specific questions.

Record-keepers — It’s important to identify important document categories beforehand, particularly those that track closely with topics for the SMEs. Ordinarily, record-keepers will not have direct contact with the FDA, unless this person is also serving another Inspection Team role.

Audit Facilitation Audit : General Rules

  • Work stations/ desks are neat, clean & tidy.
  • Noise levels in the office/bathrooms/canteen/stairwell etc. and especially around the room where the audit is taking place.
  • Inspector may "tour" the office building. Ensure employees are aware of this.
  • Know what other visitors will be on site on the day so there are no surprises.
  • Keep visitors car parking space free/ reserved and be ready for the auditors arrival.
  • Have a designated “War Room” and “Runner” for expected audit documents.
  • Assign a lead audit facilitator (lead SME) as a focal point for the auditor.
  • Have Subject Matter Experts (SMEs) available to answer


  • Be Prepared
  • Be Courteous and Polite
  • Be Prompt and Professional
  • Be Cooperative with colleagues
  • Be Confident and Positive
  • Consult procedures, notes, documentation and resources as needed
  • Listen attentively to the question asked
  • Answer only for the Question Asked
  • Ask for clarification if you do not understand the question


  • Don’t take anything personally – Auditing is not criticizing
  • Don’t Leave the auditor on their own for long periods of time
  • Don’t Be Argumentative or Overly Opinionated
  • Don’t Be Rude
  • Don’t Be Anxious to please
  • Don’t Be Gullible
  • Don’t Be Easily Diverted/Distracted

Read also: Understanding the 4 Types of FDA Inspections

Resource Person: Chakrapani K V C

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