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This article was originally published in The Tan Sheet

Executive Summary

FDA approves process validation for five of the company's OTC drugs -- acetaminophen 500 mg tabs and caplets, children's acetaminophen fruit-flavored 80 mg tabs, children's acetaminophen grape-flavored 80 mg tabs, and dimenhydrinate 50 mg tabs -- Biopharmaceutics reported Oct. 7. In a Sept. 28 letter, FDA told the firm, however, that the agency "will need to verify by inspection that the deviations have been corrected and that Biopharmaceutics is in compliance" with GMPs. The company's operations were shut down in November 1991 when FDA won a temporary restraining order. The firm subsequently committed to correcting GMP problems in a consent agreement with FDA ("The Tan Sheet" Aug. 2, p. 17). The company plans to continue its validation program for an additional 15-20 OTC products.

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