- Upon inspection of Wockhardt's Shendra-based facilities, FDA employees found evidence of inaccurate record-keeping, deleted records and improperly labeled and filed pharmaceutical ingredients.
- Now, Wockhardt must come up with a plan and tell the FDA how it will deal with the deficiencies.
- Two of Wockhardt's eight plants in India have had export bans placed on them by the U.S. Those bans will not be lifted until the FDA is satisfied that the issues have been sufficiently resolved. Wockhardt's Chairman Habil Khorakiwala had previously pledged that any FDA-related issues would be addressed within two months, but that was before the issuance of this report.
The FDA has intensified field-force activity in India to rout out problems like the ones recently identified at Wockhardt and other companies such as Sun Pharma and Cipla. There have been numerous quality-control concerns at biopharma manufacturing plants across India, which has slowed the growth of the $15 billion biopharma industry in the country.
Those issues have also led to tensions with massive markets such as the United States and Europe, which have levied import bans on many drugs manufactured in Indian plants. That's a particularly large hurdle for Indian biopharma companies since most of the US generics supply comes from the nation.