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Executive Summary

WEST-WARD MANUFACTURING BACK ON-LINE UNDER JAN. 6 CONSENT DECREE; the generic drug firm hopes to resume shipments of products manufactured in its Eatontown, N.J. plant on Jan. 27. Prior to the shipping go-ahead, however, West-ward's products must pass FDA inspections to insure compliance with current good manufacturing practices. The first inspection, for 12 products, began on Jan. 15, West-ward said. FDA filed an injunction request in Trenton, N.J. federal court against West-ward on Nov. 8 after finding GMP violations at the company's Eatontown facilities during a July/August inspection ("The Pink Sheet" Nov. 25, p. 7). West-ward Pharmaceuticals agreed on Dec. 19 to a consent decree "providing for shut-down of the firm," according to FDA's Jan. 8 "Enforcement Report" ("The Pink Sheet" Jan. 13, T&G-12). West-ward noted that, while distribution of products manufactured by the company was halted pending inspections, the company's distribution of approximately 20 products manufactured by other firms has not been interrupted. The consent decree calls for West-ward to submit for inspection lists of "a minimum of 10" products at a time that have been certified by "an independent consultant" to be in GMP compliance. West-ward said it intends to be inspected for about 12 products every six working days. The company indicated that three inspections should be sufficient to clear all its products. The consent decree directs West-ward to reimburse the government for the product-specific inspections and for its court costs. Able Labs, which also faces an FDA injunction request stemming from alleged GMP violations, said it is still in negotiations with the agency. A hearing on FDA's request is scheduled for Feb. 25, the company said, although the firm hopes for a resolution before that date.

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