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Forest Labs

Executive Summary

FDA April 9 warning letter cites the company for good manufacturing practices deficiencies in the production of Levothroid (levothyroxine) and Armour thyroid tablets during a Feb. 2 through March 13 inspection. FDA cited the company for failure to appropriately investigate uniformity/dissolution problems following a recall of Levothroid 75 mcg tablets, to establish appropriate in-process sampling, and to investigate out-of specification test results. Forest also failed to maintain and control a purified water system in the manufacture of Armour thyroid tablets that was found to contain Pseudomonas...
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PS032107

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