Document B8zaM6Y1RnnZ9dEJ97wNp7m4j

i _ JohnsonJohnsonJohnson BABY PRODUCTS COMPANY SUBJECT Geigy Purchase of Windsor Talc To Mr. D. D. Johnston RARITAN N.J. 08869 June 14 1977 Ted undoubtedly filled you in on the situation At our last contact point he had left it that the development man at Geigy would call me to give me the details I have attached some supporting documents but here is the problem in a nut shell 1 Geigy apparently decided to use Windsor Talc Grade 100 as a pharmaceutical adjunct in the manufacture of Preludin an depressant normally prescribed only for adults with moderately continuous use Approxi- mately three years ago they pleaded with us to supply them more material since they had not cleared another talc for this drug 2 Roger Miller cannot retrieve a copy of the former Geigy purchase order He does recall that he was directed by someone in our management to ship the order to Ciba an action he was not in favor of 3 In April the Geigy purchasing people got to Ted West in an effort to buy another 20,000 lbs of talc In the course of doing so they sent two purchase orders one to Windsor one to New Brunswick The purchase orders create two problems First they state that the talc is USP grade Windsor talc will sometimes pass the USP test but we never test product for it nor is it part our specification The second portion of the requirement present on the New Brunswick copy of the purchase order but not on the Windsor was a microbial requirement While I feel that the Windsor tale would pass that requirement I am not ready to certify that to Geigy Protected Document to Protective Order erm JNJTALC000092993 e Ny To D. D. Johnston . - 2 - June 14 1977 Situation at Geigy Dr. has Shibica who is Vice President of Development and indicated that the purchasing people had informed Control his lab- oratory people sometime ago that a new talc was going to be required about it for this product Shibica however just last week He indicates that he believes found out it could take between six and twelve months for them to clear a new talc He was not sure that they had secured new talc samples for evaluation It is obvious that there was a mix between their purchasing people and the laboratory about the necessity of clearing a new talc for this product My guess is that they will not have ample supply of the Windsor material to carry them through and will therefore have to make a management decision about whether they wish to switch sources of supply The FDA Problem | | | I We investigated the implications of selling a pharmaceutical | aid to a drug manufacturer on Windsor If the talc is used as an aid and not a drug Windsor will as a manufacturer of raw materials for However it is possible that we may be not have to register the drug industry inspected in the future as a supplier as a result of any implication of that drug product or an inspection of Geigy On the other hand Ciba may purchase a talc which is not certified as USP and then perform their own testing to demon- strate that it meets USP requirements for their use Recommendation Neither Roger Miller George Lee nor I are anxious to sell talc to Geigy I would recommend that we inform them that we do not plan to supply any further talc to the drug industry regardless of the specification requirements If you feel that position is too extreme I would suggest that we provide them quantities for twelve months of pro- duction and that the talc be shipped to them clearly identi- fied not as USP and without a microbial specification Geigy is perfectly capable of testing the talc to determine if it is USP the and they also advised me they are capable of decontaminating talc in the event that it does not pass their microbial standards Protected Document to Protective Order ww JNJTALC000092994