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Uploaded on Jul 2, 2010
Hi-Tech Pharmacal Co. (HITK) announced it received a warning letter from the FDA.
The warning letter primarily dealt with the marketing of several products that FDA states require FDA approval and manufacturing practices related to those products.
The company will respond to the warning letter and intends to meet with FDA to determine how best to resolve these issues. Hi-Tech is suspending sales of these products until the issue is resolved. Sales of these products totaled approximately $5 million in fiscal year 2010. Other than the suspended products, Hi-Tech does not anticipate any interruption in supply of its products.