Document LE2NXwwk53ED1ZenZqke3Xqd

I THE UPJOHN COMPANY KALAMAZOO, MICHIGAN 49001 TELEPHONE (616) 382-4000 April 30? 19 76 Office of HARRY R ALLEN. M D Manager, FDA Liaison Domestic Pharmaceutical Medical Affairs Hearing Clerk Food and Drug Administration Room L-6 5 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: In compliance with the Federal Register Notice, Volume Lo, Number 51, March lL , 1975, page 11865, titled "Asbestos-form Particles in Drugs for Parenteral Injection", we are supplying the attached memo as an updated report for replacement of asbestos filters. Very truly yours THE UPJOHN C0MPA HRA:pjc Attachment Harry R. Allen, M.D. Manager, FDA Liaison 7SP'O SG / sup I t As reported in March a study is underway to show the acceptability of the Scott BNR filter as a replacement for the asbestos filter. The 1/4 production size lot of S.A.S. Diurnal Penicillin Readimixed 500M has been manufactured and filled into vials. Stability will now begin. The production size lot of S.A.S. Diurnal Penicillin Readimixed 300M will be made as soon as Sterile Vehicle is available. lad i