India OKs Wockhardt plant banned by FDA

An Indian plant operated by Mumbai-based Wockhardt was banned in May from shipping products into the U.S. when the FDA issued an import alert. The FDA warning letter that followed laid out significant problems there. Then, European regulators issued their own import alert against the plant. But India's office of the Drug Controller General of India (DCGI) has decided the problems at the facility are not bad enough to take any punitive action.

Following its own inspections, the DCGI has asked Wockhardt to respond to deficiencies its inspection team found at the Aurangabad facility, according to The Economic Times. An official told the newspaper that depending on what the company tells the agency, inspectors may return to make sure promised improvements are being made. "The inspection team found a few lapses in Wockhardt facilities but none of these deviations from good manufacturing practices noted under the Drug & Cosmetic Act are grave enough to warrant either a lock-up of its facility or an immediate suspension of the company's drugs in circulation," the official told the newspaper.

The FDA was not nearly so sanguine. Its warning letter said that during a March inspection, quality-assurance personnel tried to hide records of batch failures, started to destroy test samples the inspector wanted to see and failed to show inspectors all areas of manufacturing for the U.S. The inspectors later learned of a cartridge-filling area they were not shown.

The Wockhardt warning letter says an inspector found records that had been put in the trash and asked that they be retrieved. Instead, the inspector was given different records. The inspector went looking for the trashed records and found them hidden in another area. "Because you directed FDA investigators away from the requested documents, and because the FDA investigator was impeded by having to locate and reassemble torn records that FDA had requested and had the authority to inspect, you delayed the inspection," the warning letter reads. The team also found a puddle of urine in a bathroom near the sterile manufacturing area.

Wockhardt Chairman Habil Khorakiwala has said the company would shift manufacturing from the Waluj plant to another facility to minimize the financial fallout from the import alerts but has acknowledged the U.S. alert could cost it up to $100 million.

According to The Economic Times, the DCGI also sent a letter to Ranbaxy Laboratories saying it had found no serious problems during recent inspections of plants in Dewas and Paonta Sahib. The two plants are named in a $500 million settlement the Indian generics maker reached in May with U.S. authorities after authorities found serious quality problems there some years ago.

- read the Economic Times story