FDA jumps to Out Side Expert Consultant for company compliance Audits

In a recent FDA warning letter issued January of 2010, the FDA resorted to requiring the company as part of their corrective action to obtain certification by an outside expert consultant, that he/she conducted an audit of the company’s quality system. The following is an excerpt from the FDA warning letter:

“xxx We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR, Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted tothis office by the following dates:

• Initial certifications by consultant and establishment – July 27, 2010
• Subsequent certifications – January 27, 2011 and January 27, 2012

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed xxx”

What was interesting was that the FDA audit for this company was conducted on November 23, 2009 which was only 60 days prior to the issuance of this W/L. From what we can determine there were no other regulatory problems the company was involved in.

This FDA issuance of a W/L of this type was a very rapid response by the FDA and definitely is a major change in the FDA regulatory compliance policy.

This is not the first time the FDA has used the policy of requiring a certification by an outside consultant but it appears that it is the first time the FDA has used this policy on the first warning letter. It would appear that when the regulatory situation is not too severe (the risk assessment on the device is not critical and the FDA inspectional observations are not too serious) the FDA does not want to waste its man-power in conducting re-inspections.

What is interesting is that the FDA has requested that this company conduct a corrective action audit 6 months from the issuance of the W/L and then two additional audits through Jan 2012.

With this policy the FDA can keep tabs on companies that are having a hard time in maintaining compliance without expending man-power and using their resources on more critical compliance issues.

From reviewing the 483 points for this audit, it would have appeared that the warning letter could have been avoided with the proper response made in the critical time frame post FDA audit. The FDA regulated industries have to understand dealing with the “new” FDA requires a whole new philosophy and your actions have to be prompt, immediate and have impact on the FDA to demonstrate your determination to bring the operations into compliance and then assure continued compliance. Remember avoiding the issuance of a Warning Letter is crucial to your regulatory health. A warning letter prevention begins with continuous assurance of internal compliance by using internal auditors as well as third party auditors(experts).

If you have any questions on this FDA update or want some assistance on your regulatory problems, email us at info@mdiconsultants.com and reference the FDA Update of May 14, 2010.