Roche Carolina

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Anonymous said:
So, how about all of the rumors that people created for no reason? The plant had issues that the previous "old" management created and look at the plant now. Let's see, still in business, doing better than ever and yes, some from the left coast came and they helped the plant be better. Let's chalk this up to better business. Out with old and in with the new!! Roche Carolina is back and has learned from the past.[/QUOT
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Quick recap:

Did Roche ever share a summary with the staff to show that there ever was the scale of problems originally reported to the entire Roche world back in December 2011? No. Was there ever an unbiased third party report? Yes. Read the EMEA reports by each of the six products issued in mid 2012 based on 1) independent analysis of the Roche Carolina data and 2) German and UK regulatory inspections conducted in May 2012 and whether the Genentec identified deficiencies had an impact on quality and safety. Conclusion: The identified deficiencies did not have an impact! The EMEA had a broad range of marketing authorisations they could have chosen to recommend. They concluded to choose to 'maintain.' They did not chose to vary, suspend, or withdraw across the EU. The audit bravehearts (corporate and for-profit) were livid that they did not even chose to slightly downgrade the authorisation one bit! Tons of money, time, and resources squandered and professional reputations destroyed. What a farce! Oh, just the EU, what do they know? The FDA came in and basically issued a routine Form 483 with some very minor issues around the same time!
 






Really, I hate to say it, but they should just out source everything and put the plant back up for sale. I'm not sure that isn't the real plan anyway. Plant's back in operation but capicity utilization is dropping.
 






Nobody wanted it the last time (when we actually had some capacity utilization) so what on earth makes anybody think someone will want it this time with declining capacity utilization (and increasing headcount).
 




































Anonymous said:
With our new processes in place and our new investments in HVAC we will be the most efficient and advanced API site in the world. Stop with the naysayers.
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"If you build it they will come" was only true in the movies. I don't see how you can call us the most efficient API site in the world especially with the Quality Gestapo having to approve everything down to the installation of a roll of toilet paper and sheep who follow the cheerleader.
 


















With the new quality systems, the improved processes, the expert leadership from the left coast, the efficiency enhancements and the new hvac the site should be an easy sell.
 
























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