Process Validation Again Among the Top Five in the Warning Letters Report for Medical Devices

After the big number of warning letters published in 2004 (104) and 2005 (106), the total number decreased to "just" 79 warning letters in 2006. However, the number is still higher than in 2002 and 2003 (61 each).

There is some movement in ranks 2 to 5, although the "usual suspects" reappear time and again among the top five. Like in the previous years, CAPA was the top offender in 2006. Meanwhile, process validation has reached rank 5 again. While it ranked 2nd in 2002, it slid down to rank 8 in 2003, occupied rank 9 in 2004 and went slowly up to rank 7 in 2005.

The following table gives an overview of the top five deficiencies (WLs = warning letters):
 

 
The table lists only the endings of the CFR numbers.

• 21 CFR 820.20: Management responsibility
• 21 CFR 820.22: Quality audit
• 21 CFR 820.30: Design controls
• 21 CFR 820.70: Production and Process control
• 21 CFR 820.75: Process validation
• 21 CFR 820.80: Receiving, in-process, and finished device acceptance
• 21 CFR 820.100: Corrective and preventive action
• 21 CFR 820.198: Complaint files