Thursday, December 18, 2014 10:22:41 AM
During a teleconference on October 23, 2013, FDA asked you to voluntarily cease sterile production until further notice because FDA did not agree with your decision to resume sterile production on or around September 5, 2013. During that teleconference, you made it clear that you would not cease sterile operations at that time. A visit to your firm by FDA investigators on January 16, 2014, revealed that the firm ceased sterile compounding at the end of November 2013, and management stated that the firm would close within a few weeks. An e-mail from your attorney, Mr. Kim J. Sveska, dated January 21, 2014, asserted that your firm planned to cease all operations and formally close as of February 16, 2014. However, on June 6, 2014, you confirmed in an e-mail to Dr. Tina Pawlowski, FDA Compliance Officer, that although your firm is not producing sterile drug products, it is “attempting to utilize this time to salvage non-sterile business and is “in the process of winding down its business operations…to terminate the business incorporation in its entirety.”
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418709.htm
"If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny." - Thomas Jefferson
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