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Executive Summary

FDA DISPUTE WITH FLOW LABS CENTERS ON VALIDATION of production processes -- especially sterilization procedures -- according to material filed by FDA and the company for an Aug. 27 court hearing on FDA's Aug. 22 seizure of products and raw materials at Flow's McLean, Virginia tissue culture facility. The court hearing was held before Federal Judge James Cacheris in the U.S. District Court in Alexandria, Virginia. Debate over FDA's seizure at the Aug. 27 hearing indicates that FDA moved against the McLean facility because the agency was not convinced that an extensive refurbishing program by Flow in June was complete. Flow voluntarily shut down the McLean facility in June following a series of FDA inspections and began shipping products again in early July. FDA alleged that the changes made by Flow in manufacturing process have not been satisfactorily validated. The Flow incident indicates that FDA is not willing to permit a mfr. to start manufacturing again at a facility which is under regulatory observation until a full validation report has been submitted to the agency. Stuart Silverman, the asst. U.S. attorney representing FDA before Judge Cacheris on Aug. 27, explained that during a July 2 meeting between FDA officials from the Baltimore district office and the company, Flow "was told of a deficiency in their GMP (good manufacturing practices)." Silverman added that "FDA was told that the deficiency would be rectified by October sometime. And then subsequently that date has been changed to September, and it's bounced back and forth from September to October." Silverman identified the GMP deficiency as "validation. Full validation." Flow attorney James Phelps (Hyman, Phelps & McNamara), argued that ". . . validation has been completed for the processes in Flow Laboratories. It was completed as of August.The only thing that is not completed," he continued, "is the write-up a write-up by the people who have done the work that they will submit." Flow's validation of production changes "still needs to ne analyzed," Silverman told the Federal District Court at the Aug. 27 hearing. "It's raw data," Silverman maintained. "A consulting company (BRACKET)which Flow(BRACKET) has hired has not analyzed fully the data." Flow voluntarily shut down its McLean, Virginia facility for refurbishment in June, following receipt of a list of FDA inspection observations. The company restarted operations July 2, after spending "in excess of $600,000" for plant and procedure changes, according to Flow's attorney James Phelps. Part of Flow's redesign of its McLean operations included the hiring of outside consultants -- ex-FDA GMP and microbiology experts Carl Bruch, PhD, of Skyland Scientific and Bernard Loftus, of Fairfax, Virginia. With respect to validation of sterilization procedures, Loftus said in an Aug. 24 statement to the court that "one of the most important things that had to be done . . . was the requalification and certification of the sterilizers. This work has been completed and the company has a letter from the consultants stating so. There have been validation runs, three for each load configuration, on every sterilizer load configuration. This is state of the art validation." Before the sterilization tests were completed, Loftus continued, "commencing July 2, 1984, the company utilized a different type of temporary validation of its sterilizers; i.e., the placement of biological indicators (BIs) . . . containing extremely resistant organisms in every sterilizer load and randomly placed throughout the loads. If those BIs remained viable (which was not the case) the sterilizer loads would have not been used in production." During mid-July, Flow "experienced a problem with tissue cultures" which caused company officials to voluntarily recall from the market 10 shipments, Loftus noted.

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