Wockhardt Ltd., the Indian drugmaker banned from selling some medicines to the U.S. from two of its factories this year, is being told by regulators to conduct a global assessment of its entire manufacturing process.
The U.S. Food and Drug Administration is questioning the reliability and accuracy of tests used to ensure product stability following its decision last week to ban some drugs from the Mumbai-based company. Wockhardt’s inability to test for quality “raises concerns about the integrity of all data generated by your firm,” according to an FDA warning letter made public today that Wockhardt said last week it received.
The FDA has targeted Indian facilities for inspection this year and curbed exports at two drugmakers, including Ranbaxy Laboratories Ltd., the country’s largest. The Wockhardt violations, which include missing drug samples and incomplete lab tests, highlight substandard conditions at plants in India, where a fifth of the world’s generic medicines are made.
“FDA strongly recommends that Wockhardt’s executive management immediately undertake a comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to FDA requirements for safety, efficacy, and quality,” according to the warning letter.
A spokesperson for the company in India didn’t immediately respond to a request for comment. Wockhardt said in September it had hired consultants, appointed a new quality supervisor and is working on a better compliance system at its Chikalthana plant.
Wockhardt’s Chikalthana plant in Aurangabad, its biggest by revenue, was added to the FDA’s “red list” last week, which means the company’s products may be detained without physical examination. The ban limits U.S. imports of a generic version of Toprol-XL, a popular heart pill that accounts for 14 percent of Wockhardt sales.
About 51 percent of Wockhardt’s $1 billion in revenue last fiscal year was generated in the U.S., with Europe serving as the company’s second biggest market, followed by India, according to data compiled by Bloomberg.
The manufacturing violations listed in the letter repeat violations revealed in a July warning letter. The Nov. 25 warning letter is based on July 22 to July 31 inspections of Wockhardt’s Waluj and Chikalthana facilities. Products from both plants are restricted by the FDA. The FDA inspected the Waluj facility in March and sent a warning letter to Wockhardt July 18 after banning medicines from the plant in May.
Bloomberg first reported on violations observed by the FDA in September at the Chikalthana plant in a filing obtained via a Freedom of Information Act request. The FDA Form 483, which lists violations that can result in a warning letter, outlined 16 observations including missing and undocumented drug samples and an instance in which a worker didn’t record observed values during testing, instead relying on memory.
The Form 483 also listed concerns with dirty worker uniforms, mold growth on raw-material storage and urinals with inadequate drainage that the warning letter doesn’t mention.
Wockhardt’s quality unit doesn’t have the ability or authority to carry out its responsibilities, the FDA wrote in the warning letter made public today. The agency recommended, as it did in the July letter as well, the company hire a third-party auditor to help detect data integrity problems.
“It is your responsibility to ensure that data generated during operations is accurate and that the results reported are a true representation of the quality of your drug products,” the agency wrote. “In response to this letter, provide a list of all the batches of drug products shipped to the U.S. market that relied upon missing, inaccurate, or unreliable test data.”