Can you hear that whistle in the distance?
The FDA recently sent a warning letter to Coats International Holdings for failure to correct GMP deficiencies noted in an earlier inspection. Coats, a contract manufacturer based in Dallas, was cited for problems with aloe-based supplements manufactured for Herbalife. According to FDA, Coats failed to adequately correct deficiencies in documentation, testing and quality control.
GMP inspections are nothing new, but warning letters are. It is apparently the first such letter issued in the dietary supplements industry over such violations. Why now?
“They were holding back until the inspectors and the agency got a better idea of where things stood in the industry,” said Wes Seigner, an attorney with Hyman, Phelps and McNamara, an FDA/FTC specialty law firm based in Washington, DC.
“They now have all the ducks in a row and now and they are going to be issuing warning letters,” he said.
So as we enter the final phase of GMP implementation, will more warning letters be forthcoming? It’s a reasonable assumption, and what is for sure is that a number of small-tier companies will not be in compliance.
“It is a certainty, for a number of reasons,” Seigner said. “The large companies tend to be better able to hire higher-paid, quality people who have experience.”
“Some of smaller companies are run by people who know what they are doing,” he said. But seat-of-the-pants operations make up a significant slice of the small-tier pie.
One resource a company can use to check its progress on compliance is this guidance recently posted by FDA that gives insight into what inspectors will be focusing on. Expect to be quizzed on manufacturing records, identity testing and product release criteria, among other things.
The tiered system for GMP implementation came about as a result of input from the Small Business Administration, Seigner said. The smallest companies, the thinking went, had fewer resources and so needed some breathing room to comply.
Well, time’s up. People get ready – there’s a train a’comin’.