FDA comes down on another Indian drugmaker

RPG asks FDA for pre-inspection and gets warning letter in response
Tools

Yet another Indian drugmaker has found itself in trouble with the FDA. Just weeks after the FDA issued a ban on products from a Wockhardt plant, RPG Life Sciences has been issued a warning that accuses it of backdating worksheets, selectively reporting test results and destroying some records of out-of-spec test findings.

The letter to RPG followed a November inspection at a plant in Ankleshwar and a January inspection at a plant in Mumbai. An RPG spokesman told the Business Standard the company had invited the FDA to inspect the plants in preparation for selling product in the U.S. He said the company is addressing the FDA concerns, although it does not currently sell APIs or drugs in the U.S.

The letter says the Ankleshwar plant sold APIs that first failed impurity tests. It said it retested the products and then reported only those with passing results. The company blamed the initial test failures on things like sample dilution error and vial contamination but had no records to verify those claims because it had not kept any records from those tests, the FDA said. Inspectors also discovered backdated quality-control sheets for APIs at the plant.

The Mumbai plant was criticized for not investigating customer complaints that APIs had unacceptable levels of impurities, tossing the samples instead. In another instance, tests found high levels of impurities in APIs returned by a customer, but RPG never checked to see if other batches of the product were also affected.

The FDA suggested that RPG get help from a third-party consultant to help it get its manufacturing in line with FDA standards. RPG tells the Business Standard it has done just that, hiring Lachman Consultants to advise it.

In May, India's Wockhardt confirmed that the FDA issued the import alert after a routine inspection found manufacturing issues with a plant in Aurangabad in Maharashtra. The company said it would shift some production to other plants but said the ban could cost it $100 million in lost sales. The Wockhardt disclosure came shortly after India's generic leader, Ranbaxy Laboratories, finally settled its long-running problems with U.S. authorities. The company paid $500 million in penalties and pleaded guilty to 7 felonies charging it with selling substandard drugs in the U.S. and lying to authorities about it.

- here's the warning letter
- read the Business Standard story

Related Articles:
Wockhardt acknowledges FDA ban, says it could cost $100M
Ranbaxy makes manufacturing strides, many dictated by consent decree
Ranbaxy pleads guilty in $500M case
Ranbaxy inks record-setting $500M manufacturing settlement with the feds
Ranbaxy brings in U.S. consultants as part of consent decree

Filed Under