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ABLE LABS IS UNDER COURT-ORDERED GMP INSPECTION BY FDA

Executive Summary

ABLE LABS IS UNDER COURT-ORDERED GMP INSPECTION BY FDA: the inspection began March 4 and must be completed by March 17 under an order issued by Newark federal court Judge Alfred Lechner. The order was issued on March 2 after a hearing on FDA's November request for an injunction to shut down Able Labs' South Plainfield, N.J. generic drug facility. FDA alleged that the plant exhibited violations of good manufacturing practices ("The Pink Sheet" Nov. 25, 1991, p. 7). Judge Lechner's order stipulates that "FDA will issue a list of inspectional observations, if necessary, by 17 March 1992," at which time the agency may clear Able Labs entirely or require "a suspension of all or any part of Able's operations." The order further stipulates that "Able may obtain limited court review of FDA's direction, based on the inspection, that operations be suspended." The court has "reserved time for such review on 19 and 20 March," the order says. During the hearing, Able maintained that it has come into GMP compliance since FDA filed the injunction request. The company presented testimony from outside consultants who have inspected the facility and found it to be in compliance, the agency said. In a press release announcing the ruling, Able noted that one of its outside consultants was John Zarembo, PhD, one of the authors of the Kibbe report on "Fairness in FDA's Generic Drugs Program" ("The Pink Sheet" May 13, 1991, p. 4). Lechner's order also enjoins Able permanently "from prospectively violating the [FD&C] Act and implementing regulations." The court ordered Able to pay the cost of the inspection, up to $5,000. Able Labs co-owners Murty Vepuri and Paul Manning said March 2 that "we are delighted that FDA and Judge Lechner have agreed that we can continue to manufacture and ship without interruption." They added that "we intend to continue our policies of full compliance with all legal requirements and full cooperation with FDA." In November, FDA began actions against four generic companies to shut them down for GMP compliance problems. Two of the companies -- Biopharmaceutics and West-ward -- now have been cleared to resume manufacturing and shipping. Biopharmaceutics said it was cleared on Jan. 10 and FDA began inspecting West- ward's product line as a precursor to relaunch on Jan. 15 ("The Pink Sheet" Jan. 20, T&G-15). West-ward announced Feb. 26 that its first lot of 12 products had been cleared for shipment. Zenith Labs, meanwhile, remains in discussions with FDA over compliance at its Northvale, N.J. facility; an April hearing date has been scheduled in that case. FDA is also currently inspecting Barr Labs. Following September inspection reports on the firm's Northvale, N.J. and Pomona, N.Y. facilities, FDA threatened to seek an injunction against Barr ("The Pink Sheet" Nov. 11, 1991, p. 15). Reinspections of the two facilities commenced in mid-February, Barr said, and may end by March 13. The firm said it has made all changes that it committed to in discussions with FDA following the September reports. Barr added that FDA is also inspecting the firm for additional products.

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