CDER Update - FDA Recalls

The Center for Drug Evaluation and Research (CDER), the FDA center responsible for chemical drugs, protein drugs and monoclonal antibodies regularly publishes statistics for the respective fiscal year. The fiscal year 2007 is currently posted on the FDA homepage.

One statistic of interest to the GMP sector concerns inspections carried out by the FDA. In 2007, the FDA carried out 289 pre- approval inspections and 1119 cGMP inspections. 333 of these were performed outside the United States, including two biological inspections. In 2007, cGMP inspections resulted in 15 actions, including 14 warning letters and 1 seizure. 67 inspections of producers of medical gases resulted in two warning letters.

A second interesting study concerns recalls in the United States in 2007. With 987 recalls, this number is twice as high as in 2005 and about three times as high as in 2006. What is the reason for this immense increase?
It is attributable to the high number of recalls on the part of one repacker who recalled over 670 products in 2007.

The most frequent reasons for recalls in 2007 are listed below:

  • Correctly labelled product in incorrect package
  • Inappropriate storage temperature
  • Subpotent (single-ingredient drugs)
  • Chemical contamination
  • Impurities/degradation products
  • Failing USP dissolution test requirements
  • Labelling illegible
  • Marketed without authorisation
  • Lack of assurance of sterility
  • Label mix-up
  • Stability data do not support expiration date
  • Microbial contamination of non-sterile products

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)


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