FDAs GMP Supplement Inspections

Until the recent implementation of FDAs 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 inspectioneven 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 facilitys 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 companys 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 companys 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.

Standard inspection preparation also includes understanding that investigators are permitted to inspect only labels, labeling, finished goods, in process material and raw material, and to take samples of each of these items. Access to documentation is otherwise limited. Similarly, investigators normally should not be allowed to communicate with employees other than the designated representative unless there is a specific reason to do so. The basic idea is to try to get the inspector the limited information he or she is seeking and then out of the facility.

A GMP inspection, however, is going to be much more involved. If you operate a manufacturing facility with more than 20 employees, starting this June (though some facilities started seeing inspections at the end of 2008), it is likely a team of FDA investigators will appear at your door and announce they have come to conduct a review of GMP compliance. This inspection will involve a review of all written policies and procedures, a physical inspection of the facility, including the equipment and material storage space, equipment maintenance logs and calibration records and even training procedures. While industry counsel have questioned whether FDA can legally take copies of the numerous documents that relate to these aspects of a facilitys operations, during the GMP inspections FDA has thus far conducted, the agency has asserted it has the authority to do so. To date, it appears no company has challenged FDA on this point, and it is possible that none may ever do so.

In dealing with so sweeping an inspection, companies will need to re-evaluate their policies on who can interact with investigators, as it may become necessary to have various department heads explain specific aspects of the companys GMP program as it applies to their area of responsibility. Even if such interaction is necessary, it is important to ensure any such interviews take place under controlled circumstances with designated company representatives present.

In order to appreciate the scope of these inspections, consider that the GMP inspection at NBTY, which took place at the companys Boca Raton facility, occurred over six days between Aug. 25 and Sept. 5, 2008. A copy of the Establishment Inspection Report issued after the inspection was closed can be found on FDAs Web site. When reviewing this document, it is possible to understand the scope of this type of inspection. The 13-page document lists numerous labels sampled, department heads interviewed, processes (including training) reviewed, and findings concerning virtually every aspect of the facilitys operations from the moment raw material arrives at the loading dock to its release for shipping to customers and the handling of ensuing customer complaints. NBTYs inspection also included its on-site laboratory operationsa critical area that could be ripe for regulatory pitfalls. Each of these areas was closely examined in order to ensure the company had prepared adequate GMPs and was following them.

As FDA moves to more fully implement the GMP inspection program, it can be expected that the six-day inspection will become much more common than the six-hour inspection. Any company that is not prepared to cope with this evolution may face the possibility of a significant, unwanted, regulatory interaction that could go as far as concluding that every product released out of a facility is adulterated. The time to get ready is now, not after this has happened.

Marc Ullman, Esq., is a partner in the New York-based firm Ullman, Shapiro & Ullman (www.usulaw.com). His practice includes representation relating to FDA compliance, regulatory issues, FTC proceedings and litigation.