Mumbai-based Wockhardt Ltd. was banned from selling some medicines to the United States from a second factory in India after regulators added it to a list of restricted facilities. The ban limits U.S. imports of a generic version of Toprol-XL, a popular heart pill that accounts for 14 percent of Wockhardt sales.
The company’s Chikalthana plant in Aurangabad, its biggest by revenue, was added to the FDA’s “red list,” which means the company’s products may be detained without physical examination, according an FDA statement. FDA is authorized to refuse admission of regulated articles based on information other than the results of examination of samples -- a strong reminder to the importing community that FDA is a regulatory agency, not a quality control laboratory.
The Wockhardt violations, which include missing drug samples and incomplete lab tests, highlight substandard conditions at plants in India.
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