Taro Pharmaceutical Industries Ltd. announced that the company has received a warning letter on February 5, 2009 from the US Food and Drug Administration (FDA) regarding the inspection of the company's Canadian manufacturing facility in July 2008. This is the first such letter that the company or any of its affiliates has ever received.
The observations set forth in the letter include concerns about certain of the company's quality control systems, including failure to complete investigations of quality issues in a timely manner.
The company is committed to working with the FDA to resolve all issues expeditiously. The company further said that it plans to respond to the letter within 30 days, as required. In addition, the company said it has already corrected many of the observations cited during the July 2008 inspection. Corrective actions began immediately following the inspection last year and are still underway, including the retention of quality control consultants.
The company noted that the observations cited in the letter do not relate to any of the company's other facilities. It is also noted that until remedial action is complete and the FDA has confirmed compliance with current Good Manufacturing Practices (cGMP), new applications listing the Canadian facility as a manufacturing location of finished dosage forms may not be approved.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.