FDA Inspections: How Long Should They Take?

how long FDA inspection

How long should an FDA Inspection take?

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.

How long should FDA Inspections take

What are Reasonable Hours for Inspection?

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?

length of FDA inspections, how long?

Should There be Timeframes for Warning Letters?

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.

GxP Perspectives LinkedIn Group

3 Responses to FDA Inspections: How Long Should They Take?

  1. PMendoza says:

    While FDA audits do not top the list of experiences most folks want (ie-not on my bucket list) they should occur over the time it takes to get the audit done. Your post did not include the quantity of data reviewed, any unexpected factors extending the audit, experience of the inspector, or other detail that could provide one with enough info to say too short/long, etc. It goes back to do you want it done right or fast?

  2. Bob Coleman says:

    Carl, There may be many valid reasons for an inspection to occur over an abnormally long period. Based upon the findings presented, I would suspect that either competing interests of an FDA matter or of a personal matter are at play. Of course, there is the possibility that the CSO is simply not efficient. One way to better gauge the time is to look at the EIR which if done in Turbo format will clearly identify the actual days spent on site.

    • GxP Perspectives says:

      Dear Bob and Pam,

      This took me a while to figure out how to respond as both Bob and Pam raise very valid points. As I said in my post, I have anecdotal evidence of inspections taking too long and not being conducted professionally. As we know anecdotal evidence isn’t solid research, but this is a blog, not a peer reviewed journal. The sources I heard from are very solid and I think that there is a problem with the length and tenor of recent FDA inspections. Others can and will disagree because we definitely need a strong FDA conducting GxP compliance inspections. My own perspective is that FDA has room for improvement in the conduct of inspections.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: