FDA Releases Ugly Novartis 483 for Lincoln NE Plant

FDA Releases Ugly Novartis 483 for Lincoln NE Plant

May 1st, 2013 // 1:03 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

Novartis decided to give it up last week and announced that it was going to shrink drug manufacturing operations at its Lincoln, NE plant. They now only plan to make powder and solid products there, which include Excedrin headache pills, Theraflu, and Sentinel, which is a pet painkiller. At this time, this means that 300 jobs are being cut, or about 40% of the total workforce. This major move was about 18 months after the drugmaker admitted that it had major cGMP manufacturing problems at the plant.

When it came public with this decision, Novartis stated that there were a total of 57 inspections by various health authorities, and 10 by FDA, during Q1 this year, and they said most were good or at least satisfactory. Two point here – passing an FDA inspection without a 483 is good, but FDA views their requirements as the bare minimum standard. FDA actually wants and expects you to do more than to be merely ‘satisfactory’ in adhering to cGMP guidelines.

Second, Novartis did not say how many inspections they failed or what the details were of the cGMP problems. But now, we have a better idea of just how bad things were at the plant, because FDA released the 483.

Novartis once again was cited for many serious cGMP violations. Some of these included:

  • Failing to investigate consumer complaints
  • Failing to do annual product reviews
  • Failing to extend their investigations of problems into all lots of product that were affected
  • Not filing field reports on time, and failing to store stability samples properly

In the EIR, FDA notes that a team of complaint investigators closed 1065 cases as of October 2012, but nine cases were selected for review by FDA. None of them addressed all products that could be affected by the problems reported. This was found with several different drug products, so is indicative of a pattern.

Also, the EIR noted that when the plant employees closed one complaint about a child being able to open a bottle of cough syrup, the QC unit knew there were 90 bottles with similar defects. And they had held meetings about child-resistant caps failing.

There are many more examples of the major cGMP problems at this Nebraska plant, which you can see in the 483 yourself. These serious problems show how even with major managerial changes and millions of dollars spent on consultants, systemic problems are tough to solve. With the level of failure, it is not likely that Novartis was going to get back contract manufacturing business in enough quantity to keep that plant at full capacity.

Novartis definitely could have used better senior management to ensure that its plant was cGMP compliant. The sad thing is, strong managerial oversight of quality is much more cost effective than a messy 483 or warning letter clean up.

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