December 15, 2015

What Happens During an FDA Inspection?

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From drugs to medical devices to nutraceuticals and imports, the FDA inspects all manufacturers that produce products to GxP standards for compliance.

Under the Federal Food, Drug and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years––even more for companies just getting started, those with a history of compliance problems, and those who have started producing products significantly different from what they produced before.

With a stepped effort by the FDA to monitor the growing number of manufacturers entering the market, many new companies struggle to understand what to expect and how to prepare when inspectors show up at their door.

While the FDA’s Investigations Operations Manual offers the best complete resource for preparing to host an inspector auditor, or any other compliance specialist, we’ve summarized a few of the basic things to prepare for no matter what manufacturing space you’re in.

1. Arrival and introduction

It’s one of the biggest questions new manufacturers ask:

“Will we be notified of an upcoming FDA inspection or not?”

The short answer: Maybe, maybe not.

Inspectors aren’t required to give notice of their arrival ahead of time, but if they don’t, they still need to make their presence known when they arrive.

Once an inspector arrives at your facility, he or she will present official FDA identification along with the FDA form 482 Notice of Inspection which clearly lays out what the inspector may and may not inspect during their visit.

As a general rule of thumb, it’s best to meet the inspector at arrival and discuss the agenda for the day. Most importantly, be sure to set aside time at the end of each inspection session to review, answer questions and provide clarification on anything the inspector might want to know more about or may have seen as a problematic.

These review periods can go a long way in avoiding additional exploration and can clear up any misunderstandings that pose problems down the road. If the inspector notes a problem you’re currently addressing, take the time to clearly lay out your process improvement with them one-on-one.

2. Facility inspection and audit

After giving official notice of inspection and running through the agenda, the inspector will get to work. Here are a few of the things they’ll look for when assessing your Quality Management System (QMS):

  • A quality policy: You’ll need to show that you’ve established a quality policy that applies to each on-site operation.
  • An appointed management representative
  • Deviation reports
  • Regular management reviews: Inspectors will want to see evidence that your organization conducts management reviews on a regular basis.
  • Internal audits: Inspectors will want to see that not only are you auditing internally, but that you’ve put a standard procedure for doing so in place.
  • A quality plan: Inspectors will want to see you’ve established a list of goals for ensuring quality moving forward.
  • Statistical evaluation of product data
  • CAPA procedures: Inspectors will want to see you’re making an effort to investigate and correct quality issues to prevent recurrence.
  • Risk analysis: Inspectors will want to see that you’ve put any and all appropriate risk monitoring systems in place and that you’re routinely assessing relevant risks within your operations.
  • Product recall and rejection reports
  • Equipment and instrumentation calibration and maintenance reports
  • Training procedures: Training is an important component of any inspection. Inspectors will want to ensure all operations are supported with adequate training systems.
  • EHS control charts
  • Internal investigations into failures: If problems have occurred which lead to any kind of failure, inspectors will want to see documentation showing you’ve investigated the root causes of those issues and made the appropriate adjustments.
  • Manufacturing processes validation reports
  • Product and process performance reviews: In addition to other internal audits, inspectors will want to see that you’re routinely reviewing the performance of your products as well as the processes that go into producing them.

This is just an abbreviated list of the inspection points common among manufacturers in general. Read the FDA’s Investigations Operations Manual for a complete explanation of the investigations process.

3. Closeout meeting

After completing their audit, the inspector will meet with company management to review the findings and bring to light any issues they found along the way.

Keep in mind that the closeout meeting isn’t simply a report. It’s meant to start a discussion to better understand the regulatory deficiencies and any steps you’re currently taking to remedy them.

Following the closeout meeting, the inspection will come to a close.

4. Post-inspection procedures

After the inspection is complete, you’ll receive a letter from the FDA documenting the inspector’s findings.

If regulatory deficiencies were found, they’ll be listed in the FDA form 483. In addition, the inspector will give a timetable or rough timeline by which any corrections should be made.

Lastly, you’ll be given instructions on how to respond to these observations.

After your responses are received, the investigator will write and submit an Establishment Inspection Report to the compliance office. If major compliance problems or any other kind of legal violation was identified, the Agency will take further disciplinary actions as needed in the form of warning letters, consent decrees and/or detentions.

Want to learn more about regulatory and compliance auditing and the FDA? Grab our free whitepaper: GxP Audits Overview.