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FLOW LABS WILL RE-WORK IN VITRO DIAGNOSTICS UNDER FDA SUPERVISION

Executive Summary

FLOW LABS WILL RE-WORK IN VITRO DIAGNOSTICS UNDER FDA SUPERVISION as part of an Aug. 31 consent decree extricating the firm from the seizure action filed by FDA on Aug. 22. According to the consent decree, Flow agrees to withhold the seized products from the market until the firm has brought the products into compliance with the FD&C Act "under the supervision of a duly authorized representative of the Dept. of HHS [FDA]." Flow said further that it will "voluntarily refrain from new production of in vitro diagnostic products at its McLean [Va.] facility until certain facility improvements currently in progress are completed." Flow said the consent decree, arranged by its outside counsel James Phelps (Hyman, Phelps & McNamara), effectively resolves proceedings arising from the seizure. The consent decree also gives Flow a grace period of three months to complete its GMP improvement project which was ongoing at the time of the seizures. During court hearings on the seizure, Flow reported that it had hired outside consultants to perform a full validation of its production processes. The U.S. Asst. District Attorney handling the case for FDA told the court that full validation would not be complete until September or October. The consent decree gives Flow time to finish that process. One of the company's outside consultants, former FDA GMP expert Bud Loftus, explained the extent of GMP work going on at Flow in an affidavit to the court. "The amount of qualification and requalification of equipment and personnel since the FDA inspection ended in early June has been enormous and will be ongoing. We invited FDA to visit the plant during the refurbishing and requalification stage, but they declined to do so because of other commitments." The consent decree assures FDA participation in Flow's continued attempt to revise and requalify its production procedures. Flow predicted: "Shipment of some in vitro diagnostic products will resume in four-to-six weeks, and the balance of the entire line of in vitro diagnostic products is expected to be available again in approximately 12 weeks." Flow said that at the same time that it is addressing FDA's GMP concerns it is effecting a "'significant upgrading' of the company's biological products manufacturing facilities 'to remain competitive in terms of production costs and product quality.'"

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