FDA Inspections and Warning Letters Continue to Decline

April 5, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Mar. 1)-The number of US Food and Drug Administration inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs.

Rockville, MD (Mar. 1)-The number of US Food and Drug Administration (www.fda.gov) inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs. This total has decreased since 2002, when the agency reported 4570 inspections.

The report states that the Center for Drug Evaluation and Research (CDER) conducted 2411 domestic and foreign inspections in 2006, compared with 2682 in 2005. The number of CDER inspections is at its lowest point since 2002, when the center reported 2585 inspections.

The Center for Biologics Evaluation and Research (CBER) also conducted fewer inspections in 2006. The center reported 1826 domestic and foreign inspections in 2006, a decline from the 1931 inspections during 2005. CBER’s inspections have decreased since 2003, when the center’s annual total was 2205.

In contrast, both CDER and CBER issued more Class I recalls in 2006 than in 2005.

A recall is an action taken by a firm either to remove a product from the market or to conduct a field correction. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death, according to FDA.

CDER’s total of 45 Class I recalls in 2006 is the greatest number of the past five years and an increase from the 18 such recalls in 2005. CBER issued 13 Class I recalls in 2006, compared with a single such recall in 2005. In 2006, CBER issued more Class I recalls than in 2005 and 2004, but fewer than its recent peak of 24 in 2003.

The report also shows that the number of Warning Letters issued by the two centers has declined during the past 10 years. In 2006, CDER issued 66 Warning Letters, and CBER issued 22 Warning Letters.

For the full text of the report, click here.