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Whitehall-Robins' Today Sponge

This article was originally published in The Tan Sheet

Executive Summary

Firm says it will not reach its previously stated goal of reintroducing the OTC contraceptive sponge into national distribution by the end of this year due to unresolved GMP issues raised by FDA during recent inspections of the company's Hammonton, N.J. plant. An FD-483 report on an agency inspection in June/July notes that the water system used in the manufacture of products including the sponge "continues to lack assurance of the absence of objectionable microbial contaminants. The June/July FDA inspection was the agency's second and latest visit to the Hammonton plant this year. "The Tan Sheet" incorrectly reported Oct. 24 (p. 8) that the plant has had three inspections in 1994. Whitehall-Robins' Madison, N.J. facility was the site of an FDA inspection in late summer
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