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Human drugs.

Publication: Warning Letter Bulletin
Publication Date: 16-DEC-02 		Format: Online - approximately 699 words
Delivery: Immediate Online Access

Article Excerpt
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Abbott, Abbott Park, IL, Sept. 24 (Chicago). The letter cited Abbott with failure to conduct a thorough investigation "when a batch or any of its components fail to meet specifications." Specifically, the agency noted that during production of an unnamed product "black, magnetic particulates were observed in the granulation," and that the corrective action taken was not validated. FDA also hit the firm for failing to "clean, maintain and sanitize, at appropriate intervals, equipment and utensils used in the manufacture, processing, packing, or holding of a drug product." The letter continued citing that the black particles found in tablet granulations were due to...

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