FDA Inspections Down in 2006

Domestic and foreign FDA inspections of biologic and drug manufacturing facilities declined in fiscal 2006, from 4,513 in 2005 to 4,237, according to a recent report from the FDA's Office of Regulatory Affairs.

Inspections of facilities regulated by CDER totaled 2,411 in 2006, down 279 from 2005, while inspections for CBER-regulated facilities decreased by 126 to 1,826 for the year, according to the report.

In addition, there were 58 Class I recalls in 2006, down from 19 in 2005. There were 45 recalls for CDER-regulated products and 13 for CBER products. Class I recalls are classified as the most important corrections, representing products with a "very serious potential to cause harm, injury or death," according to the FDA.

Last fall, sources said that CDER's decision to perform 45 Class I recalls in 2006 represented a shift in enforcement policy. One such action highlighted in the recent report was Bedford Laboratories' recall of 8,570 vials of preservative-free methotrexate due to an active pharmaceutical ingredient that contained low levels of ethylene glycol.

Although the number of Class I recalls spiked last year, the total number of recalls, including Class I, II and III, for both CDER and CBER products declined by 750 to 2,202 for the Oct. 1, 2005, to Sept. 30, 2006, period, the FDA said.

The enforcement report said CDER issued 66 warning letters in 2006, while CBER issued 22. The report highlighted several letters to compounding pharmacies. Following the conclusion of fiscal 2006, the agency continued to cite compounding operations, despite a court ruling reducing its authority to regulate compounding pharmacies.

The report can be accessed at www.fda.gov/ora/about/enf_story/default.htm.