Hi-Tech Pharmacal Co, Inc has received a warning letter from the US FDA. The warning letter primarily dealt with the marketing of several products that US FDA states require US FDA approval and manufacturing practices related to those products.
The company will respond to the warning letter and intends to meet with US 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 totalled approximately US$ 5 million in fiscal year 2010. Other than the suspended products, Hi-Tech does not anticipate any interruption in supply of its products.
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products for the general healthcare industry. The company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The company's Health Care Products Division is a leading developer and marketer of branded prescription and OTC products for the diabetes marketplace. Hi-Tech's ECR Pharmaceuticals division markets branded prescription products.