If the aspiration of Baxter CEO Robert Parkinson is “zero
defects,” then the recent Warning Letter at their plant in Puerto
Rico suggests that they have to get back to the basics.

The Warning Letter dated January 20, 2011, is very
diagnostic of endemic issues where all the signs were there, but the symptoms
were apparently ignored until it became another in the long line of regulatory
enforcement events.

The symptoms were the “fabulous four” of pending failure:
(1) not thoroughly investigating failures; (2) not listening to customer
complaints about their failures; (3) not reporting these failures to the FDA;
and (4) not resolving these failures, which were previously cited by FDA.

But to exacerbate the malady, Baxter chose to mask, rather
than treat the underlying sickness.

The Warning Letter revealed an equipment failure that affected
the color of the otherwise colorless liquid product. What was the Baxter
approach to fixing this problem and work toward achieving zero defects?

·Baxter concluded in their investigation that healthcare
professionals would detect the discolored product and not use it.

·Baxter developed and distributed a color chart to provide
instructions to end-users when to use or not to use their product.

It was no surprise that the FDA editorialized, “It is
unacceptable to rely upon the health care professional to fulfill your Quality
Control Unit responsibilities…The end user should not be expected to make a
determination of product safety and effectiveness…”

Mr. Parkinson said to analysts after the citation was
issued, “Clearly, I’m not happy to have to communicate that we got a Warning
Letter. Our aspiration is zero defects here. We are better than we were, be we
have to get better.”

So—what’s the strategy, Mr. Parkinson? What system do you
need to put in place that would have alerted you to the “fabulous four” in time
to intervene? What was the role of QA in all this? And, for Pete’s sake—whose
idea was the color chart?

Mr. Parkinson also knows (certainly now via the Warning
Letter) that Baxter also has had an insect problem in their saline solution. So
if I were Mr. Parkinson, I would be asking around whether someone in his
organization was preparing an insect chart.

Class Assignment: Go to the following link and research all
the Warning Letters across all the Baxter operating units. (1) How many do you
count over what time period? (2) What are the common themes and underlying
messages? (3) Outline a high-level corporate strategy for Mr. Parkinson to
become an anticipating organization with respect to taking responsibility for
the product quality/regulatory compliance.

 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#browse.

 The QA Pharm