Taro Cited for GMP Violations at Canadian Facility

The FDA has expressed concern that stability failures and other out-of-specification results for Taro Pharmaceutical’s creams did not lead the generic-drug maker to withdraw the products or shorten the expiration period on them, according to a warning letter.

The letter, which Taro says is the company’s first, cites the drugmaker for GMP violations at its plant in Brampton, Ontario. Two of the products were corticosteroid creams fluocinonide and betamethasone valerate.

Three of 24 Taro lots of fluocinonide failed to meet the ANDA limit for the relative standard deviation of tube uniform stability at 18 months and 36 months. Taro took no action to reformulate the cream, reduce its shelf life or pull the product from the market, the letter says.
Drug GMP Report