How to survive an FDA inspection

Although we may be tempted at times, denial is not a recommended life strategy. That's true in many areas, not the least of which is the eventuality of an FDA inspection. "One of the biggest mistakes companies make is telling themselves, FDA will never come and inspect me," says Jim Shore, Principal of Quality Lean Solutions, who also serves on the boards of directors of the American Society for Quality, Biomedical ASQ Div., and American Welding Society. "By law, the agency is supposed to conduct an establishment inspection audit of every Class II and Class III device manufacturer every two years," he notes. In reality, FDA has resource constraints, so it identifies companies to audit based on risk potential. If you think that puts your company under the radar, you might be living in denial. Not a good idea, remember? Shore and John Freije, Principal Consultant, Freije Quality Engineering, will address FDA inspections and related issues at the upcoming MD&M Chicago exhibition and conference. They shared some insights with PlasticsToday in advance of their session.

Knowing that FDA must prioritize inspections based on the potential risk of products or processes, companies would be well-advised to evaluate their risk profile, says Shore. "Look at customer complaints, adverse events, industry communications, and comparisons with your competitors," he suggests. For example, FDA issued a safety communication on surgical mesh in 2011. If you're involved in the production of surgical mesh, which was the object of product recalls and lawsuits, your odds of being inspected greatly increase. "It's important to watch industry activity that could raise your risk profile," says Shore.

Despite the fact that FDA can make an unannounced inspection, a large number of companies still don't have procedures in place for such inspections nor have they trained their staff appropriately, says Shore. Preparing for an FDA inspection is like doing a fire drill: Would you do a fire drill without knowing the basics such as where to assemble and how to do a proper headcount? The same goes for an FDA audit. "Everyone needs to know what to do when the FDA agent shows up, from the person at the front desk knowing who to call to inspection-facing staff understanding their role," says Shore.

Resources to help you prepare are just a mouse click away. "Go back to the audit elements in the Quality System Inspection Technique document and make sure your processes, procedures, and records are ready. Also, make everyone familiar with the Investigation Operations Manual, which outlines the steps the investigator must follow," says Shore.

One mistake that less-experienced employees have been known to make during an inspection is to provide records to the FDA investigator that have not been reviewed first, says Freije. "Before the document is handed to the investigator, it should be reviewed so you are not caught off guard by any questions he or she might ask. This should be part of a company's FDA inspection procedure or training. I recall one inspection of an infusion pump company where I was consulting," says Freije. "During the tour of the facility, the investigator asked the manufacturing engineer if he could review the cleaning log. Without hesitation, the engineer provided the record. Luckily, there were no issues noted with the cleaning log," says Freije.

Perhaps the single-most important piece of advice Freije and Shore give to companies is to maintain an open line of communication between FDA and top management that shows a commitment to improvements. Remember, they caution, that FDA can authorize product seizures and place companies under a consent decree. All of this is public knowledge and can harm your company's reputation, not just with FDA but with your customers and stakeholders, they warn.

Shore and Freije will discuss FDA inspection issues as well as supplier quality agreements during an afternoon session on Oct. 16 at MD&M Chicago, which runs Oct. 15 and 16 at the Schaumburg Convention Center. Go to the event website for complete exhibition and conference information.

— Norbert Sparrow

Norbert Sparrow is Senior Editor at PlasticsToday. Follow him on twitter @norbertcsparrow and Google+.