OVERVIEW OF AN FDA INSPECTION

Do not panic. As long as you are calm, organized, and informed, you and your team can make it through your inspection. For this post, we’ll give a general overview of the inspection process so you’ll know what to expect. Let’s get right to it.
 

KINDS OF INSPECTIONS

There are four basic kinds of inspections: pre-approval, post-approval, surveillance (routine), and for-cause.

In most cases, you will receive a 482 Notice of Inspection prior to inspection.

To get a better idea of the inspection from the investigator’s viewpoint, consider the information he or she goes over before his or her visit. The investigator creates an inspection plan based on your organization’s previous inspection reports, responses to form 483 observations or warning letters, your organization’s website, events since the last inspection such as complaints, recalls, ADEs and FARs. The inspector will go in having a general game plan regarding inspection priorities.
 

BEGINNING OF INSPECTION

At the beginning of the investigation the inspector will show his or her credentials (this is required by law) to the top management official such as an owner or agent in charge. These credentials may not be photocopied, but the name and number may be written down.
 

These credentials give the inspector the right to examine employees, conduct inspections, to collect samples, and to verify and copy records.

The lead investigator will then provide a general agenda.

The investigator(s) will tour the facility with a knowledgeable person such as a manager accompanying him or her.
 

DURING INSPECTION

Technically, there are things outside of the FDA’s scope such as pricing information, employee information, etc. However, inspectors are known to be human, and some inspectors might not respond very well to objections, so it’s prudent to weigh the risks vs. benefits when reminding any federal employee of his or her scope.
 

During the inspection, the inspector is limited to “reasonable” requests. This is a broad term. However, if the inspector requests anything that is unreasonable or difficult to produce, the issue can be brought up in a discussion. Chances are, that the inspector will be reasonable if he or she is made aware of any extenuating circumstances.
 

At the end of the day there will be wrap up meetings. At this time it’s a good idea to verify that the inspector has received all requested documents, to bring up any concerns that need to be addressed right away, and to ask if there are any items he or she may want to review or discuss the following day.
 

Keep in mind that different inspectors during the same inspection may request the same documents, so it may be a good idea to make copies and then replace the document right away so that it will be in its proper place should the next inspector request it.

If the inspector brings up any issues, it’s a good idea to fix them right away if at all possible. Do not wait until the inspector finishes his or her investigation. The FDA wants to see that immediate actions are taken, and will be judging attitude and responsiveness.

In addition to making sure its regulations are being followed, the FDA also wants to see:
 

   - that management has necessary control over the organization

   - well-trained employees

   - well-maintained facilities and equipment

   - good process control

   - a history of conducting investigations, resolving failures, handling complaints, etc.

   - that management is already aware of any problems

   - that you have written SOPs and staff have been trained to follow them
 

INSPECTION WRAP-UP

When the inspection is complete, an Establishment Inspection Report will be written and a copy provided to the organization. From this report a final report is written: the FMD 86 Establishment Inspection Report Conclusions and Decisions. It will list any actions the organization needs to take or any sanctions it faces.



If a re-inspection needs to happen to follow up on any violations, there may be fees associated with it.