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09/09/16 12:59 PM

#226681 RE: PH4RM4C3UT1C4LS #226678

In the case that I posted for SKB, I find it flabbergasting that this Major Pharma has major Penicillin contaminations from air ducts. I have done considerable CSO work in Penicillin facilities and these criteria are at the top of the list to assure against.

Smith Kline Warning Letter Jun 30, 2016

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm511838.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/default.htm?Page=4