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"FDA-TYPE INSPECTIONS" AS COMPANY DRY RUNS ARE RECOMMENDED

Executive Summary

"FDA-TYPE INSPECTIONS" AS COMPANY DRY RUNS ARE RECOMMENDED before actual agency facility inspections occur, FDA Chicago District Director Raymond Mlecko said Feb. 11 at a Food & Drug Law Institute meeting on FDA enforcement and inspections held in Washington, D.C. Providing suggestions on how companies can improve their "peace of mind" about inspections, Mlecko recommended: "Periodically, make FDA-type inspections to reveal those kind of violations that the FDA would find." "If you find any of these violations, give them... corrective action as quickly as possible," Mlecko said. The FDAer noted that "many firms will use a team from within the company to make these inspections." However, "there are certain dangers in that, because if people are familiar with an operation...they may not see the violations that are existing," so firms might want to use outside consultants. Mlecko suggested also that "every firm have an SOP [standard operating procedure] covering an inspection." The SOP, he said, should establish who will officially meet and accompany an FDA investigator, who will take notes during the inspection, what the company's policy is on investigators taking photographs, what the policy is on FDA requests for various records and how a company will respond if an FD483 report is issued. FDA Richmond Resident Post investigator Troy Williams also had suggestions for how companies can expedite FDA inspections. The first point, which Williams repeated several times, "is comply with the law." Have a "well-defined quality assurance program in place and operating in your firm," he added. If the firm has a good QA program ongoing, "the FDA inspection is only going to confirm what you already know." Williams recommended that firms have all pertinent documents together in one folder ready to give to the investigator. "Have all your significant records: organizational charts, product list, master records, production records, process and control records, complaint files, investigations, submissions to the agency such as NDAs, ANDAs -- have all of those things organized and ready to be inspected at any time." In addition, it would be helpful if companies had "production control records, quality assurance data and the like, complaints, trended," Williams said. "Be able to present summary data of this." As one final piece of advice, the FDAer added: "Don't keep the CSOs [investigators] waiting." The advantages of mock inspections were highlighted by industry at a Feb. 5-7 Drug Information Association meeting on preapproval inspections. Ortho Regulatory Inspections and Auditing Manager Steven Martino encouraged companies to conduct internal audits before preapproval inspections. Martino also suggested that companies prepare to have FDA conduct a validation inspection concurrently with a preapproval inspection so that a firm is subjected only to one inspection. Ortho has "tried to have one inspection; that's the way we've gone," he said. FDA Deputy Associate Commissioner for Regulatory Affairs Gary Dykstra informed FDLI that Terrell Vermillion, the newly appointed director of the agency's Office of Criminal Investigations, will be "on board with us as of March 9." Vermillion has been a special agent with the U.S. Secret Service for 23 years. Of the approximately 100 criminal investigators FDA plans to recruit, the agency hopes to have 30 to 40 of them hired by September. Noting that FDA is bringing a lot of criminal cases, especially fraud cases against drug companies, Mlecko commented: "I can assure you that there are some cases out there that I am aware of that would actually make your hair stand up on end." Remarking that "there are a significant number of bad actors out there," Mlecko cautioned the FDLI audience that "I would predict that in the coming year, a number of these people are going to be brought to trial." The FDAer added that "the problem is that these bad actors...are ruining it for the entire industry. They are ruining it for the people that are trying to comply with the law."

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