Lessons Learned from the Mistakes of Others Question 8 Martin Browning, EduQuest, Inc.

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

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 System’s 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.

Is the Firm in the Clear with FDA? In short, no. Ace’s 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.

What can Ace do to help Rebuild 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

What can Ace do to help Rebuild 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