When the FDA knocks on your door to conduct an inspection, you need to be prepared. Pre-planning is important so that procedures are in place prior to an inspection, and you are not making rash decisions after the inspectors walk in the door.

Decide Whether to Let Inspectors In

If you decide not to let them in, they will eventually make their way in, and you will face the consequences. You may be escalating the situation, causing a more intense inspection with more serious warning letters or subpoenas. If you appear insubordinate, the FDA may be more hesitant to approve your pending applications and you may also face stricter audits.

If you let the inspectors in, you appear compliant and will be subject to less serious fines if problems are found. Although everything they observe will be evidence and can be used against you, it is generally advised to let them enter.

Have Your War Room Ready

Your planning should also include setting up a war room in which key personnel respond to inspectors’ requests, prepare the required documents, and monitor the inspection proceedings.

Set up teams: a point of contact team, an inspection team, an agency response team, and a media response team (for larger companies). Decide who will be present in your war room.

  • The point of contact team should be three or four people who will first greet the inspectors. This group will be responsible for gathering the teams and sending out necessary information.
  • The inspection team should consist of a leader to consult with stakeholders, a spokesperson, as well as multiple scribes to take notes on all proceedings.
  • The agency response team can include different people, depending on your decisions. It may include: a lawyer, principal investigator, office manager, regulatory person, sponsor representative, or CRO representative. They will write a response to the FDA after the inspection.

Decide What Information to Let Inspectors Have

  • Are you going to waive privilege for information? In some states, you can partially waive privilege.
  • Are you going to let them have access to confidential information, such as trade secrets?
  • Are you going to disclose financial information?
  • Are you going to give them access to internal audit records?

Have Standard Operating Procedures in Place

  • Identify all non-essential personnel, and decide if they will be present during an inspection. Inspectors will generally want to observe routine operations as they occur on a daily basis.
  • Decide if you will record the meeting and if your lawyer will be present. This may change inspectors’ attitudes.
  • Have a template email ready to send out to inform employees when an inspection occurs.
  • Make sure employees are compliant, but do not offer extra information without prompt.
  • Do not leave the inspectors alone, and find out if the audit is routine or with cause.

Be Aware of the Latest Enforcement Areas

Another important point is to understand the latest enforcement areas the FDA is focusing on and the most common problems they’ve uncovered recently.

For more information on this issue, contact the Kulkarni Law Firm.