Until the recent implementation of FDA’s inspection program under the new dietary supplement GMP (good manufacturing practice) regulation, perhaps the greatest change in agency inspectional procedures in the previous decade was the adoption of the principle that if your facility was operating, it was subject to inspection—even if the “management” was not on premises.
This was a substantial change from prior practice where it was common for a dietary supplement company to suggest to FDA investigators that “it was not a good time” for an inspection and for the inspector to agree to return at a later time. However, as FDA adopted a philosophy that “if there is someone here with enough authority to supervise the facility’s operations, then there is someone here with sufficient authority to receive a Notice of Inspection,” investigators no longer would leave to return at a more convenient time and inspections would take place whenever the investigator presented his or her credentials.
As the dietary supplement GMPs have begun rolling into effect, FDA has commenced implementation of its GMP inspection program. These inspections represent far more than a change in agency procedure; they are a sea change in the manner in which supplement manufacturers interact with investigators. The days of trying to figure out how you are going to manage your facility while FDA is walking around for a couple of hours, or even a couple of days, are now in the past. When FDA appears at your door for a GMP inspection, you may very well be talking about running your facility for a couple of weeks while FDA pokes around.
In many ways, preparing for a GMP inspection will be similar to preparing for any other FDA inspection. It will be essential for all employees who will interact with the investigator to understand their role in the inspection as well as the company’s rights and obligations to FDA. When counseling clients on these issues, I always stress the importance of training each person who may come into contact with the FDA investigator from the moment he or she enters your facility. This includes the receptionist, who should know to ask the investigator for a copy of his or her credentials as well as the Notice of Inspection. More importantly, the receptionist must know to immediately contact the company’s designated representative responsible for dealing with an inspection and to ask the investigator to wait for that person to arrive. It is not unheard of for receptionists to panic when a government official flashes a badge and just simply invite them in to do their business. This is not the preferred course of action.
