The US FDA doesn't make its own regulations. Those are controlled by Congress, which means FDA regulations are slow to change. What FDA does control are its policies – how it asks the medical device industry to interpret Congress's regulations. These can change rapidly and a mistake in interpreting them can mean an FDA warning letter with significant business consequences.

This is how mdi Consultants was born 40 years ago. Its founder and executive vice-president, Alan Schwartz, is a former FDA supervisor of field investigations who now employs other ex-FDA staff as consultants to provide clients with insider knowledge. The company's global client base includes everything from start-ups to Fortune 50 companies.

Rules and regulations

Several of those clients have recently been struggling with a particular section of FDA regulations: the Corrective and Preventive Action (CAPA) requirements of the quality system regulation (QSR), also known as current good manufacturing practices (CGMP). Though the most recent revision to the CGMP was in 1997, manufacturers are still often unsure how to implement CAPA – and it's affecting their products' path to market.

We understand that working closely with FDA is the only way that you're going to be able to get a company out of a situation.

The CAPA subsystem is meant to be used to identify potential and actual problems with products or quality. It allows action to prevent these problems by communicating the issue, documenting it and providing information for management to review. The problem, says Schwartz, is that companies focus too closely on the 'corrective' part of CAPA. They use it to address every individual complaint, non-conformance or failure.

"CAPA is actually supposed to be looking at trends," he explains. "If you see trends developing, then you impose a corrective action in order to bring the trend back into compliance or into an expected level of failure."

If FDA finds anything that could constitute a violation of the Food, Drug and Cosmetic Act during an inspection, it issues a document known as Form 483 – a precursor to an official warning letter, if company management does not respond to the form. "CAPA is usually the number one point on 483s, and it's usually the number one point when FDA issues warning letters," says Schwartz.

For US-based companies, a warning letter is a wakeup call to correct the problem: if it remains uncorrected, the next step is legal action by FDA. Warning letters are also difficult to market around and companies may find they make life difficult if a product is up for approval. If a company is based outside the US, the consequences are more immediate: a warning letter can prevent them from shipping to the US for up to a year. Once a letter has been issued to a client, mdi Consultants' first priority is to get it lifted as soon as possible.

Sharp strategy

Schwartz's strategy has been honed from years inside the administration. The consultant helps the client draft a corrective action plan so it can respond to the warning letter. Then they make sure the plan is implemented, including extra staff training, keeping FDA in the loop the whole time. Finally, the consultant runs a mock audit to assess the client's readiness and asks FDA to run a new inspection. If the client passes, the warning letter is lifted.

"We understand that working closely with FDA is the only way that you're going to be able to get a company out of a situation. You have to be able to put yourself in FDA's shoes, what it's looking for," Schwartz says.

On the bright side for Schwartz's clients, the current FDA stance is focused on voluntary compliance. "Numbers of warning letters have greatly decreased in the past year," Schwartz says, adding that he expects that to continue into 2018, when the US is scheduled for mid-term elections.

When so much depends on the whims of Congress, a warning letter can have a significant impact on sales. It makes sense for manufacturers to have a backup plan, and 40 years' of inside knowledge isn't a bad start.