FDA Bars Imports From Another Indian Manufacturer

The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality.

Canton was warned by the FDA last month for a litany of quality violations. The warning letter stemmed from an April 2013 inspection of the drugmaker’s API plant in Vadodara.

For instance, the company failed to properly test microbial limits for three batches of API. Canton was also cited for failing to properly investigate customer complaints, perform stability studies and clean equipment after use.

Canton is the latest Indian drugmaker to be slapped with an import alert due to GMP violations. To lift the Apr. 10 alert, the company must demonstrate that it has made strides in improving quality and meeting good manufacturing practices.

Apotex’s Bangalore manufacturing plant has been barred from importing drugs, as have Sun Pharma’s and Marck Biosciences’ India-based sites.

If your company is no longer allowed to export products to a specific country, it’s because the FDA inspected your operations and didn’t like what they saw. The Ninth Annual FDA Inspections Summit is coming this fall. Be there to have all your questions answered by experts. Sign up now.