Black particles at Abbott lead to unvalidated corrective action citing. (Human Drugs).A just-released Sept. 24, 2002, letter cited Abbott's plant in Abbott Park, IL, (Building AP-16) with failure to conduct a thorough investigation "when a batch or any of its components fail to meet specifications." Specifically, the agency's Chicago district office noted that during production of an unnamed product "black, magnetic particulates were observed in the granulation granulation /gran·u·la·tion/ (-shun) 1. the division of a hard substance into small particles. 2. the formation in wounds of small, rounded masses of tissue during healing; also the mass so formed. ," and that the corrective action A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or taken was not validated. The inspection occurred June 18-24 and the inspectors were not identified in the letter. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. also hit the firm for failing to "clean, maintain and sanitize To remove sensitive data from an information system, a database or an extract from a database. See sensitive. , at appropriate intervals, equipment and utensils used in the manufacture, processing, packing, or holding of a drug product." The letter continued by citing that black particles found in tablet granulations were caused by "the disintegration of the mill's drive damper damp·er n. 1. One that deadens, restrains, or depresses: Rain put a damper on our picnic plans. 2. An adjustable plate, as in the flue of a furnace or stove, for controlling the draft. and grease seals," and that "there was no established schedule for inspecting or replacing these parts." In a Jan. 17 phone interview, Abbott spokeswoman Melissa Brotz said the agency had returned to Building AP-16 in order to re-inspect. Because the company received FDA approval for its daily version of Depakote for epilepsy in December, Brotz said she was "pretty sure" everything had been cleared up with the agency. Doc. 12146W |
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