Wockhardt says FDA impressed by the strides it made at a banned plant

FDA actions against Wockhardt have piled up over the last couple of years with warnings letters for two plants in India that the FDA also banned in 2013 from shipping products to the U.S. But the Indian drugmaker suggests one of those facilities has started digging out from under the mountain of issues raised by the FDA.

Wockhardt in a disclosure Wednesday with the Bombay Stock Exchange said the agency recently made a re-inspection of its Chikalthana plant after the drugmaker in October submitted its report on its remediation efforts, and the strides it had made "to bring about a culture change and to build a robust quality management," the filing says.

"The efforts for data security control has been thoroughly verified during the inspection and have been appreciated as it is qualified and executed since September 2013," Wockhardt reported. "There are no findings with respect to data security and control measures in Laboratory and Manufacturings."

Data integrity was a big issue when the FDA banned the plant in 2013, as did regulators in the U.K. A warning letter faulted the Chikalthana for manipulating testing data, for allowing unhindered access to computers where data was stored and then noting that some data that was required for an audit trail had in fact been deleted.

The observations that the plant did receive in the re-inspection were tied to products manufactured at the plant before it started its remediation, Wockhardt said in the filing without providing any details.

The FDA has also banned a Wockhardt plant in Waluj in 2013 after finding some of the same data issues as well as noting concerns over sanitation. Wednesday's filing made no reference to the status of that remediation

In fact using "trial samples" to get passing test results so drug batches won't have to be destroyed has been an issue the agency has found at any number of Indian manufacturing facilities. The agency has also banned plants owned by Canada's Apotex and Sun Pharmaceutical at least in part for the same kinds of hijinks, as well as at four plants owned by Ranbaxy Laboratories, which Sun is in the process of buying.

Given that U.S. sales account for the biggest chunk of revenue for each of these companies, getting these issues behind them as quickly as possible is key to their financial well being. In its last quarter, Wockhardt reported a 97% freefall in its profits, the second quarter in which its profits were off more than 90%.

- here's the BSE filing

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.