“The first thing I would do is to say something wrong. I’m not a quality expert. I know enough to leave it up to my quality people,” David Hinton, president and CEO of Nelson Bach, a Massachusetts-based manufacturer of herbal remedies, said during the panel discussion. The panel was part of the Rocky Mountain Dietary Supplement Forum held in Boulder, Colo. on Sept. 13 and 14.
Hinton appeared on the panel along with two representatives from the quality side, Doug Robertson, director of quality and compliance at Rhema Health Products Ltd., a British Columbia-based contract manufacturer and Teressa Street, director of quality for 4Life Research, a Utah-based dietary supplements manufacturer. The trio gave the 70-plus attendees an in-depth look at what to expect when FDA comes calling. The event was put on by Colorado-based consultancy FDA Compliance Group.
“We tell them (denizens of the executive suite) if you don’t know, don’t make something up,” Robertson said.
“From a senior management perspective I think you have to be involved in the process from the beginning,” Hinton said. But he stressed this was more in a top level support role.
“I would not be in the audit process itself. I would be in the back room. I would be there at the end,” he said.
Five-day GMP audit
Street did a blow-by-blow description of the five-day audit conducted out of the Denver district office.
“It was tough. We had one auditor and it was way more thorough than I was expecting. It was a complete Part 111 audit. I don’t thing she left any stone unturned,” she said.
“She just sat there for hours and hours and watched every process.”
Street said the FDA auditor selected four products her company manufactures and requested standard operating procedures, master manufacturing records and batch production records for those products. The auditor also reviewed training records. In addition, she said, the auditor spent an entire day reviewing the company’s testing procedures and practices for setting specifications.
To prepare for the process, Street said, her company did five internal audits and paid consultants for three external audits. It helped, she said, stressing that thorough preparation is a key part of keeping FDA audit pain to a minimum. But she went on to say that these audit must be as realistic as possible, and not be a friendly give-and-take about what needs to be improved.
To speak, or not to speak?
An earlier presentation by officials from the Denver district FDA office laid out the hope that companies would choose to be highly communicative during the audit process. “I firmly believe that the more open you are in communication, the better off we’ll all be,” said Nancy Schmidt, a compliance officer in the Denver office.
Street and the other panelists (and other speakers at the forum) respectfully disagreed.
“Of course FDA would like everyone to volunteer information. We advise clients to defer all questions to the quality assurance person,” said attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, who participated in the panel from the audience. Prochnow gave a presentation of his own at the forum on how his firm reviews label claims for clients.
Street said her company’s experience during its audit was that the auditor was completely noncommittal on what might or might not fly in terms of satisfying issues that arose during the process.
“They just give you that kind of poker face,” Street said. “(The auditor) gave us nothing on what she expected.”
However stressful, expensive and time-consuming the process might be, the panelists said, it is the law, and it can help improve your overall operation.
“That’s what I mean by ‘Embrace the process.’ At the end of the day you can be a better company,” Hinton said.