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Executive Summary

LABELING RECALL FOLLOW-UP BY FDA TO INCLUDE FULL INSPECTION of the recaller's label control operations, according to guidance to the field recently issued by FDA Office of Compliance Director Daniel Michels. "Follow-up inspections of all incidents such as recalls should not be limited to a determiantion that the recall is being adequately handled, but should also include a thorough inspection of the firm's basic controls to determine the underlying cause of the problem, where possible," Michels stated. The compliance office instructions call for particular emphasis to be placed on GMP labeling controls during inspections of newly registered drug repackagers or manufacturers. During these inspections, the guidance states, "the general level of competency of employees in these firms should be evaluated as well as the firm's training program for new employees." Special attention should be given to "unit-of-use" repackagers, the instructions state. The inspectional guidance is one of several steps recently taken by FDA to improve labeling control practices. Agency concern has been heightened by the fact that six labeling recalls over the last year have been given a Class I, or "potentially life threatening" designation. A letter also went out recently from Commissioner Young to the major drug industry associations asking for cooperation with FDA in encouraging adherence to current good manufacturing practices (CGMPS) for label controls and use of better technology ("The Pink Sheet" Jan. 18, p. 2). FDA is also working on revising the CGMP regulations to minimize problem practices and encourage the upgrading of controls. In conducting routine inspections, the compliance office guidance calls for inspectors to pay particular attention to label control procedures that have been previously associated with recalls ("The Pink Sheet" Oct. 19, T&G-10). For example, firms using cut labels that are similar in appearance without some type of 100% electronic verification system for the finished product "should be considered [to have] inadequate control over the labeling operation," the FDA directive states. Firms using outside contractors to print labeling, the guidance states, should have detailed information as to how the printer controls the printing process. "An audit of the printer should be performed by the firm on a regular basis and the drug firm must adequately examine the labeling upon receipt from the printer," the guidance notes. Two other categories of firms that should receive close investigational scrutiny, according to the compliance directive, are those which package products under a number of private labels, and those who have had multiple mislabeling recalls in the past few years. The districts are encouraged by FDA headquarters to pursue regulatory follow-up when GMP deviations regarding packaging and labeling controls are found. "Districts should consider issuance of an NAFL [Notice of Adverse Findings Letter] as a minimum," the directive states. "If significant deviations are noted at a recalling firm," the guidance adds, "the Center will be willing to consider additional regulatory action, especially if the firm has had multiple label recalls."

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