Caraco to resolve manufacturing issues with US FDA after products seizure at Detroit plant

US  FDA seized drug products manufactured at Caraco’s  facilities in Detroit in June

Caraco Pharmaceutical Laboratories, a subsidiary of Indian generic firm Sun Pharma, is speeding its the process to satisfy the US FDA requirements to resume manufacturing operations in its Detroit plant which were closed following an inspection and product seizure by the US drug regulator.

Caraco Pharma has entered into a consent decree with the U.S. Food and Drug Administration  regarding the company’s drug manufacturing operations.

The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area facilities.

Caraco is working expeditiously to satisfy the requirements of the decree and has already retained independent cGMP experts for review of the Company’s operations and to facilitate a successful result, the company announced in a press statement.

Under terms of the consent decree, Caraco’s cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the decree and regulations and can resume operations.

However, nothing in the decree prohibits Caraco from distributing FDA approved drug products that are manufactured by third parties.

US marshals, at the request of the FDA, seized drug products manufactured at Caraco’s  facilities in Detroit, Farmington Hills, and Wixom on 25th June. The seizure also includes ingredients held at these same facilities.

Generic drugs seized by federal authorities could cost Detroit-based Caraco Pharmaceuticals an estimated $15 million to $20 million in lost inventory.

The US FDA action was the result of Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities, an FDA release said.

US FDA asked Caraco to immediately stop urther distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Caraco manufactures 33 drugs in multiple strengths.The FDA seizure of Caraco’s drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers.

Caraco sells about 3.6 billion generic tablets in more than 50 products annually to wholesalers, drug distributors and retail giants.
Caraco manufactures and supplies a wide variety of drugs, including the popular diabetes medicine metformin and the pain reliever tramadol to the wholesalers, distributors, drugstore chains and managed care providers in US.