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Executive Summary

CIBA-GEIGY's QUALITY CONTROL UNIT WAS IMPROPERLY EXCLUDED from production decisions, FDA contended in a July 8 warning letter to the company. Citing the adulteration of a lot of Ciba-Geigy's Acutrim Maximum Strength Tablets, the letter maintains that the QC unit "was not party to a decision of the production department to rework an in-process batch found out of the specification." While Ciba-Geigy responded in February to FDA's specific observations concerning Acutrim, the agency commented that it views the omission of the Quality Control Unit in certain decisions as "not being restricted to the product at hand." The warning letter maintains that "this is the third instance that [FDA] investigators have documented" that Ciba-Geigy's QC unit has been left out of the decision-making process by the production department. During a Nov. 9, 1990-Jan. 25, 1991 inspection of Ciba-Geigy's Summit, N.J. facility, FDA inspectors found records showing that the production department considered multiple failures of Acutrim dissolution requirements a minor problem. The production unit "reworked" the batch, which had failed dissolution rate specifications three times, "under the guise of the operation being a correction of a 'process deviation' rather than a 'rework,'" the letter states. FDA asserted that the Quality Control Department did not know of the decision until after the Acutrim batch had been reworked. Ciba-Geigy records "clearly indicate that the three rework operations were actually performed long before the Quality Control Unit signed off on each procedure," the letter states. By using the designation "process deviation" instead of "rework" the production department may proceed without input from QC, FDA noted. "The use of semantical phrases such as 'process deviation correction' should not be used to bypass the authority of the organizational unit charged with the responsibility for controlling quality," the agency cautioned. During inspections of Ciba-Geigy's plant in March and July of 1990, FDA said it had found "identical instances" of the production unit's failure to notify QC of manufacturing problems. Products involved in those inspections were Ciba-Geigy's antiepileptic Tegretol (carbamazapine), nasal decongestants Privine and Otrivin and two unapproved new drugs. FDA urged the company to evaluate this recurring problem at the highest level of management. The "Ciba-Geigy Corporation must make a firm commitment on a corporate level to assure that the Quality Control Unit is the lead group within the company in assessing the quality of articles produced and, with input by all interested parties, make the binding decision as to their final disposition." The agency cautioned that failure of the company to control the quality of its products "will result in regulatory and/or administrative action without additional warning."

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