Document Z4bK67XbBM4310VXpmxYw9ZBp

t THE UPJOHN COMPANY KALAMAZOO, MICHIGAN 49001 TELEPHONE (616) 382-4000 March 1-4, I976 Office of HARRY R ALLEN, M D Manager, FDA Liaison Domestic Pharmaceutical Medical Affairs Hearing Clerk Food and Drug Administration Room L-65 5600 Fishers Lane Rockville, Maryland 20852 Dear Sir: In response to Federal Register Notice, Volume kO, Number 51, March lL, 1975, page 11865, titled "Asbestos-form Particles in Drugs for Parenter Injection", we are supplying the attached memo. We will give notice in the event we have not achieved the exclusive use of glass-free filter cartridges prior to September lL, 1976. Very truly yours, THE UPJOHN COMPANY HRA:pjc Attachment Harry Rr Allen, M.D. Manager, FDA Liaison jgp-OZ-b/ .1 Filter cartridges used at the present time for (1) sterile filtration of parenteral solution products and (2) filtration of services used in various sterile products processing operations contain a small quantity of glass fiber formulated into the filter media. The exclusive use of glass-free filter cartridges in these applications will depend on (1) delivery of glass-free cartridges from the supplier (Pall Corporation) and (2) depletion of the existing inventory of glass containing filter cartridges. sks a