Inspections are likely to come in “fair numbers”, but are unlikely to start for several months, according to the agency’s manager of the Division of Dietary Supplements, Brad Williams.
“It’s impossible for us to get to everybody this year. We will get to a large number, I can’t tell you exactly because I can’t predict work planning in the district nor can I predict the emergencies that always seem to come up for FDA. But our plan is to do a substantial number, like as many as 200 firms this fiscal year. It’s a very short time so I doubt we’ll hit it but we will try very hard,” Williams recently told NutraIngredients-USA.com.
FDA’s current Good Manufacturing Practices (GMP) regulation is being phased in over the period of three years: Last June, dietary supplement companies with over 500 employees became compliant; this month, the majority of players (over 20 employees) must meet the new regulations; and as of next June, GMPs will also spread to small firms.
Sometimes, we have to shake a stick
“If you become impacted from June 25, we will only look at your records as of June 26. So we’d expect a gap of time before our investigators reach your doors,” Williams recently told industry executives during a presentation at the trade show SupplySide East.
“Inspectors don’t have a check list per se, but they have been trained in what to look for,” he said.
He also suggested that if a firm passes a GMP inspection, it would be unlikely to face another one for several years.
“If we find problems, the first thing we do is we list our observations. Many times, that’s the end of the line. That’s good for us and that’s good for you because then we’ll go away and not bother you for two years. Sometimes, we have to shake a stick. Depending on what we find, it’s a big stick or a little stick,” said Williams, who is appreciated in industry as being honest and approachable in his communication.
FDA assigns districts the number of inspections that they must undertake. At a seminar hosted earlier this year by trade group United Natural Products Alliance (UNPA), Williams had said that FDA would be focusing its inspection resources on areas where the industry is “large and strong”. This includes the Utah area and Southern California.