Guidant Gets Lump of Coal in Christmas Stocking

On December 22, 2005, just three days before Christmas, Guidant Corporation received a Warning Letter from FDA detailing 8 significant deviations. This follows an FDA-483 issued in September 2005 listing 15 major observations.

The last paragraph of the Warning Letter says, "Please notify this office within 15 working days of receipt of this letter and provide an update on the status of your corrective actions."

The letter was sent Certified Mail – Return Receipt Requested.

Training Tip:

Print copies of both the FDA-483 and Warning Letter to use during a GMP training session. Discuss the impact of these FDA actions on the company.

Here are some tips on starting the discussion:

• When many people are taking time off to enjoy the holidays, Guidant’s employees are gathering to prepare their response to FDA. Imagine the impact on morale within that company.
• The cost associated with compliance activities is likely to take a big chunk of the 2006 budget, potentially leaving less for salary increases, bonuses, and profit sharing.
• Have your people come up with other potential consequences.
  

Download the FDA-483 and the Warning Letter at

www.GMPTrainingSystems.com/asp/resources.asp

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