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In Brief: McNeil plant reinspection

This article was originally published in The Tan Sheet

Executive Summary

McNeil plant reinspection: J&J division's Las Piedras, Puerto Rico manufacturing facility is ready for reinspection by FDA, the J&J unit says. McNeil received a warning letter on Nov. 18 citing deviations from the Good Manufacturing Practice regs for Tylenol products. McNeil failed to conduct potency testing on all finished product lots and dissolution testing on film-coated or gelatin-coated tablets made before July 1, 1996, the letter says. The firm notes that it has provided FDA with all of the requested information documenting product testing...





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