Average Time FDA Takes to Conduct HCT/P Facility Inspections on the Rise

The US Food and Drug Administration (FDA) conducts thousands of regulatory inspections each year. While the media tends to devote much of its attention to some of the more high-profile inspections related to noteworthy drugs, medical devices and supplement products, the agency also conducts of hundreds of inspections related to human cell tissue and tissue-based products (HCT/Ps).

Those facilities can often garner less attention than their larger, drug- and device-producing counterparts because they generally manufacture on a smaller scale, and their products are used by fewer people.

Which isn't to say that the products are in any way safer. On the contrary: because the products are biologically based, manufacturers must be careful when processing the products to ensure their safety. Donor screening, too, is incredibly important to ensure that patients are not exposed to blood- or tissue-borne diseases or conditions such as HIV or Hepatitis C.

Data

Now FDA is out with a new report detailing some of its inspectional trends over the last decade. The industry looked markedly different in 2003, the first year of data contained in the report. That year saw 218 inspections, with 160 of those being marked as "no action indicated" (NAI), generally a sign that the facility passed inspection with no substantial issues. Another 53 facilities voluntarily conducted actions in the wake of an inspection ("voluntary action indicated," or VAI), while five were ordered to conduct actions under an "official action indicated," often a sign that a warning letter has been sent to a company.

But those inspection numbers have increased dramatically since then. In 2012, FDA's Center for Biologics Research and Evaluation (CBER) conducted 598 reports, of which 432 were marked NAI, 151 VAI, and 15 OAI. That's an increase of 270%, 285% and 300%, respectively.

The increase is relatively proportional, particularly in regards to the number of inspections resulting in an OAI. In 2003, 3.13% of all inspections resulted in an OAI; in 2012, 3.47%.

VAIs exhibited a similar trend, increasing just 1.82% between 2003 (33.1%) and 2012 (34.95%).

One notable exemption from the otherwise flat trend line: hours taken to conduct each inspection. In 2003, FDA took 33.7 hours to conduct each inspection, which fell as low as 32.3 hours per inspection in 2005. In 2012, it took 39.4 hours per inspection-a 19% increase in inspection time over the past decade.

The good news: That's still down considerably from the 2007 high of 46.7 hours on average to conduct each facility, which would represent a 41% increase relative to 2003 levels.