Lessons Learned from the Mistakes of Others

1
Lessons Learned from the Mistakes of Others

• Question 8
• Martin Browning, EduQuest, Inc.

2
Is the Firm in the Clear with FDA?

• Some time has passed but it is unlikely all of
  the various FDA sanctions have ended for the
  company.
• Two of the three FDA 483 observations appear to
  be minor one-off types of errors
• Failure to date a change to a Device History
  Record and
• Failure to create a training folder for a new
  employee

3
Is the Firm in the Clear with FDA?

• The third observation is more significant
  (failure to adequately validate a rework
  procedure for one batch of tubing) and if we
  assume the product was shipped must be responded
  to by Ace following a speedy and thorough
  investigation
• A corrective action is necessary and a correction
  may also be needed.
• The Quality Systems failure to detect this error
  is significant under the scrutiny Ace should be
  applying and their processes for handling
  non-conforming material, rework, history record
  review, product release, and CAPA should be
  reevaluated.

4
Is the Firm in the Clear with FDA?

• In short, no.
• Aces compliance state for a significant period
  of time was abysmal.
• They destroyed their credibility with FDA and it
  will take a significant period of time to rebuild
  the relationship.

5
What can Ace do to helpRebuild their Image?

• Ace needs to walk a very straight and legal line
  with FDA
• They must never forget their past mistakes and
  must never repeat them at any of their locations
• Ace must be very open and responsive to FDA and
  must be constantly vigilant that their Quality
  System is effective

6
What can Ace do to helpRebuild their Image?

• Ace must recognize that cGMP compliance is the
  minimum requirement to regain credibility Ace
  must exceed the minimum
• Their processes for management oversight and
  organization must assure clearly defined
  responsibilities and must be demonstrated through
  management actions