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Executive Summary

HOFFMANN-LA ROCHE MANUFACTURING FACILITY TO BE REINSPECTED by FDA within the next two months. The firm said that FDA is moving ahead with plans to reinspect the facility following three agency inspections of the plant earlier this year, in January, April and June. FDA sent Roche a regulatory letter Sept. 5 citing eight different observations made during a January 18 through March 22, 1990 inspection. The reg letter mentions problems that may have lead to the February recall of Roche's antimalarial drug Lariam (mefloquine HCl) ("The Pink Sheet" April 9, T&G-17). A packaging defect resulted in some unit dose blisters containing two tablets instead of one tablet. Roche responded in April and May to the FD-483 issued following the January-March inspection. Roche also responded to the reg letter in mid-September. Roche said that FDA was "satisfied" with the corrective actions taken by the firm and that the company was taken by surprise by the reg letter since Roche felt it had responded to the observations in the FD-483. In the reg letter, FDA stated that "equipment qualification was not performed in that there had not been an evaluation of the capability of the foil pouch packaging equipment to consistently package one Lariam tablet in a unit dose pouch." The agency added that "there is no written procedure requiring that is to be evaluated for appropriate design prior to use on new dosage forms or different size dosage forms." The letter notes that "the product was packaged on equipment that had no set-up specifications for the Lariam tablet size." The reg letter also refers to an Accutane (isotretinoin) label mixup complaint and the company's response to it. The agency noted that Roche did not document the destruction of rejected and unused capsules from the lot involved in the complaint. "The capsules were reported to have been destroyed but there is no record of the method, the date or the individual(s) witnessing the destruction." Roche said that the mixup involved only one sheet of capsules of a different dosage from the rest of the lot. Upon investigation, it was determined that the mixup did not occur at the plant, but possibly could have occurred at the wholesale level, the firm said. Roche added that the mixup did not result in a recall. FDA also criticized Roche for not giving its quality control unit sufficient responsibility for approving or rejecting certain procedures and specifications. "The written procedures for the quality control unit do not provide for review and approval of master production and control records for packaging and labeling," the letter states. Also the quality control group "does not review or approve batch production and control records to determine compliance with all established procedures prior to release and distribution." The agency also found Roche's annual evaluations of the quality standards for drug products to be inadequate. Noting that the annual review "lists a total of 14 complaints," the agency remarked that "not mentioned are an additional 548 ADE [adverse drug experience] complaints which were received by your firm during this period." In addition, Roche's written procedures for producing the annual product review are lacking in that they "do not require the inclusion of a review of [ADE] complaints which may indicate the failure of the drug product to meet its specifications," FDA said. The letter notes that the company's procedures "do not require the inclusion of a review of discrepancy investigations" and "do not require the inclusion of a review of returned drug product."

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