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U.S FDA warns Wockhardt
By agencies
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Tuesday, 11 April 2006, 19:30 IST
WASHINGTON: The US Food and Drug Administration has warned Indian drug maker Wockhardt Ltd. over poor record keeping at its manufacturing facility in Walju, Aurangabad, according to a letter released.
The FDA, in a letter dated Feb. 21, said a November 2005 inspection of the pharmaceutical plant found written production and process control procedures were not always followed and documented.
It also cited the company for not including complete and accurate information about each production batch in its control records. In December, Wockhardt responded to the FDA's concerns, but the agency said that several areas "need more comprehensive corrections."
Two other FDA inspections also found problems with Wockhardt's record keeping. Wockhardt manufactures a variety of products, including treatments for epilepsy and ulcers, among other conditions.
It also makes products for other drug makers, including AstraZeneca Plc and Schering-Plough Corp., according to its Web site.
Dozens of FDA warning letters are issued every year. Most are resolved without penalty, but the FDA can take other regulatory action.
If the company does not correct the problem, the agency said it may deny its products from entry into the U.S. The FDA gave the company 30 days to respond to the letter.