OR WAIT null SECS
The company announced that no Form 483 was observed at the company’s facility in Bangalore, India.
On Feb. 20, 2017, Kemwell Biopharma announced that its oral solids manufacturing facility in Bangalore, India successfully completed an FDA inspection. The inspection confirmed that the site is compliant with principles of current good manufacturing practices and no Form 483 observations were issued. In a statement, the company said the audit was triggered by an abbreviated new drug application filed for a customer. This facility is part of Kemwell’s pharmaceutical business for which Kemwell has signed a purchase agreement with Recipharm.