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FDA sends warning letter to Indian drug maker

July 29, 2013
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Mumbai-based pharmaceutical firm Wockhardt Ltd has announced that it has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the import alert on production originating from the company's Waluj facility in India.

In May 2013 the FDA banned the import of drugs manufactured at the facility at Waluj, near Aurangabad, following inspections by the agency that revealed the plant, which produces injectables and solid dosages, did not meet manufacturing standards. Wockhardt stated that it had already started to implement corrective action produces. However, earlier this month Reuters reported that the UK's Medicines and Healthcare Products Regulatory Agency had stopped the sale of 16 medicines manufactured by Wockhardt after it found manufacturing deficiencies at the same facility.

In its warning letter, the FDA stated that the company's production was "adulterated" and listed alleged violations of current good manufacturing practices in the industry. The agency noted that Wockhardt had restricted and denied access to the facility to FDA inspectors. When an inspection eventually took place, inspectors found that documentation was inadequately kept and they suspected that employees at the plant had withheld important information from them.

During the inspection, FDA officials discovered both unlabeled and partially labeled vials in the laboratory glassware washing area. When an employee was approached by the inspectors with questions relating to the contents of the vials, the Wockhardt worker tried to dispose of them in the drainage sink. Later, he claimed that the content of the vials could not be determined, the warning letter explained.

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The FDA described other violations of the Federal Food, Drug, and Cosmetic Act that were detected during the inspection that took place between March 18 and March 22 this year. These included Wockhardt's failure to prepare batch production and control records for each batch of drug product that includes details of the manufacturing, processing, packing or storing of the batch. Documentation showed that about 14 percent of the vials used at the plant had defects, such as black particles, glass particles, sealing defects and volume variations.

All these examples were described by the FDA as "cause for concern" over Wockhardt's integrity and reliability as a drug producer. In its warning letter, the federal agency listed the steps it expects the company to take as soon as possible. One of these includes hiring a qualified third-party auditor who will be able to detect problems, to take part in evaluations and to assist with compliance with current good manufacturing practices.

Wockhardt will also have to appoint a data integrity consultant to make sure that all records have been fully and adequately kept. As a means to ensure the safety of U.S. consumers, the FDA requires a full list of all lots of pharmaceutical products that have been exported to the United States with inaccurate, incomplete or unreliable data. Wockhardt confirmed that it would continue to work with the FDA to "resolve the issues at the earliest."

Meanwhile, the company estimated that the impact of the import ban on its revenues would be about $100 million for this year.

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