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DELL LABS EXPECTS TO BEGIN SHIPPING CONTRACT MANUFACTURED PRODUCTS

Executive Summary

DELL LABS EXPECTS TO BEGIN SHIPPING CONTRACT MANUFACTURED PRODUCTS "in the near future," according to an April 11 letter to customers of the parenteral products mfr. Dell, under an agreement with FDA, ceased manufacturing its products in August 1985 following GMP (good manufacturing practice) related problems at the firm's Teaneck, N.J. facilities. While upgrading those facilities, Dell has been negotiating with contract manufacturers to supply its products. In the letter, Dell noted that "the transferring of our NDAs has proven to be a lengthy process. While actual manufacturing has not yet begun, we hope that the first batches will be available in the near future." In January 1986, Dell initiated a recall of all of its products remaining at the customer level following a December 1985 seizure action taken by FDA against the firm. "The delay in starting the contract manufacturing, and the recall," Dell explained to its customers, "have caused a financial burden on our company." Dell Labs is a division of the American Geriatric Drug Company.
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