MUMBAI: The US Food and Drug Administration, the apex regulator of the US pharmaceutical industry has warned pharma major Wockhardt Ltd about its poor record keeping at its new manufacturing facility in Waluj in Aurangabad.

A FDA letter released on Monday alluded to its letter dated February 21, said a November 2005 FDA inspection of the pharmaceutical plant found “written production and process control procedures were not always followed and documented,” by the Indian pharma company.

Wockhardt has major interests in the US exporting drugs directly and also manufacturing them for US drug makers.

It also cited the company for not including complete and accurate information about each production batch in its control records. Wockhardt has two manufacturing facilities in Aurangabad district — one at Chikalthana and another at Waluj.

Responding to the FDA, Wockhardt said the second plant at Waluj which is for sterile cephalosporin injectables, is yet to commercialise production for the US market.

The company which revealed ambitious plans to grow through mergers & acquisitions especially in the US, the latest stricture from the US would mean a setback, unless they sort out the issues raised by the US FDA quickly.

“Wockhardt has already complied with most of these observations,” the company said. It also claimed that the FDA’s latest communication dated April 4, 2006, the regulator has acknowledged Wockhardt’s efforts.

“We are confident that this facility will be approved in the near future,” Wockhardt in a statement said.

“Out of the pending 28 ANDA applications from Wockhardt, only three pertain to the Waluj facility,” Wockhardt said.

The Chikalthana plant accounts for almost all the existing US business of Wockhardt. As such, the FDA observations will not have any impact on Wockhardt’s business, the company alluded.

In December, the company responded to the FDA’s concerns, but the regulator said that several areas “need more comprehensive corrections.”

Two other FDA inspections also found problems with Wockhardt’s record keeping, the letter released on Monday noted.

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 website.

FDA before allowing foreign pharma companies to export medical drugs into US, makes it compulsory for the companies to adhere to inspects factories and issues warning letters to pharma companies, when there is non-compliance.