Mumbai, March 1: The problems of drug firm Wockhardt with the US Food and Drug Administration (USFDA) continued with its subsidiary Morton Grove Pharmaceuticals receiving a warning letter from the agency.

“The USFDA has issued a warning letter to Morton Grove Pharmaceuticals Inc, USA, a stepdown subsidiary of the company,” Wockhardt said in a filing to the BSE. 

The company, however, did not provide any details about the reasons for the warning letter and the date of its issue.

Even after the warning, Wockhardt’s current range of drugs will continue to be available in the market but new approvals will not be given till the company resolves the problem. 

Wockhardt said it had started taking steps since last several months to address the US drug regulator’s concerns. 

When the FDA finds that a manufacturer has violated its regulations, it notifies the manufacturer in the form of a warning letter. 

The warning letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do or incorrect directions for use. 

The letter also makes it clear that the company must correct the problem and provide directions and a timeframe to inform the FDA of its plans for correction. The FDA then checks to ensure that the corrections are adequate.

Chicago-based Morton Grove Pharmaceuticals was acquired by Wockhardt in October 2007 to expand its product line in the US. Since 1995, Morton Grove has been manufacturing and marketing oral liquid and topical pharmaceuticals.