How long will an FDA inspection take? Three days? Three weeks? Three months? Are there any rules? The most recent FDA Warning Letter to a clinical site was released last week and it was for some rather typical violations. Failure to obtain informed consent. Enrolling subjects who met exclusion criteria. Failure to report concomitant medications. These violations were compounded by the fact the clinical investigator failed to adequately answer the Form FDA 483, Inspectional Observations. They had not specified how they were going to meet proposed corrective and preventative actions (CAPA). None of these issues really caught my attention. The Warning Letter, issued by the Center for Devices and Radiological Health, seemed entirely appropriate.
What leaped out at me, however, was the fact that the inspection had taken place over two and a half months. The inspection began September 14, 2009 and was completed on December 2nd. The Warning Letter was not that lenthy or complex. Why did it take such a long time? FDA primarily regulates clinical trials at the clinical sites. Unlike a pharmaceutical or medical device company, not all clinical sites are equipped to host an FDA inspection over a ten week period. Although some clinical sites are for-profit clinical research centers, others are busy medical clinics with limited resources to handle a ten week inspection. Is this imposing an unnecessary regulatory burden on clinical sites? Two and a half months hosting an FDA inspection can cost a Lot of time, money and resources.
I have recently heard anecdotal evidence of one recent FDA inspection taking place over a six week period at a busy medical practice. the FDA field investigator was not at the site half of the time during the inspection while performing other duties. That can be difficult to arrange staff to assist the inspection. Another inspection lasted until 9:00 pm, a good 4 hours after the clinic’s business hours were over. Is that “at reasonable times” as specified by 21 CFR 312.68? Another item of interest is the length of time between the end of the inspection and the issuance of the Warning Letter. I worked on a temporary assignment at FDA headquarters in 2004. Then, there were strict timeframes when a Warning letter needed to be issued after the conclusion of an inspection. That evidently is no longer the case. For example, the Division of Scientific Investigations issued a Warning Letter on February 24, 2010 for a 3-day inspection that concluded on March 27, 2009. That’s almost a year. And it is hardly the only example. Is this an appropriate policy? Planning for an FDA inspection isn’t easy. knowing the approximate length might be helpful for smaller clinics.
You can read about FDA Warning Letters to clinical investigators on FDA’s Website. You can search by subject for “Clinical Investigators” for inspections assigned by the Center for Drugs and under “Investigational Device Exemptions (Clinical Investigators) for medical devices.
On the Blogroll: FDA Matters discusses The Hamburg Legacy in consideration of one year as FDA Commissioner for Dr. Margaret Hamburg.