In May, India's Cipla voluntarily pulled a lot of its levalbuterol from the U.S. market after the asthma inhalation drug failed a test for a degradant. Shortly after, FDA inspectors visited the plant in Indore where Cipla made the product and came away with issues tied to that recall.
Citing a Form 483, the Economic Times said inspectors were in the Cipla plant in July and August. They observed that the test failure was tied to leakage, but although the problem was documented 35 times, the plant had not investigated to determine the root cause of the failures. They also noted that Cipla didn't bother to investigate whether the degradation issue that led to the recall might extend to other doses of the inhalant.
Other observations said the plant's Quality Control unit was not given the authority to review production records to make certain that there were no production errors and investigate any that were noted.
A company spokesperson told the newspaper in a statement that "Cipla works closely with the regulatory authorities to ensure that we maintain the highest quality standards. As a policy we never comment (publicly) on these interactions."
This is not the only FDA issue facing the company right now. Cipla in September announced it would pay $550 million to buy InvaGen Pharmaceuticals to get its first U.S. manufacturing site. The deal will give Cipla both a 350,000-square-foot manufacturing facility and portfolio of drugs. But the plant in Hauppauge, NY, comes with some FDA issues of its own.
Several months ahead of the announcement, the facility was issued a Form 483 for problems that included the fact that it was not using its written Corrective and Preventive Action (CAPA) procedures so that it could track issues and determine if steps taken to fix them were paying off. Instead, they handled problems through its change of control procedures.
- here's the Economic Times story