- Federal inspectors from the Food and Drug Administration flagged 11 potential violations at Sun Pharma's Dadra facility in India following an April review of the plant, the generic drugmaker disclosed in a filing with the National Stock Exchange of India.
- Sun said it was in the process of responding to the FDA's Form 483 observation letter, which cited the drugmaker for issues with incomplete laboratory records and failure to properly investigate out-of-specification results, according to a report from Bloomberg.
- Stepped-up FDA oversight of manufacturing facilities has dogged Sun Pharma efforts to further grow sales in the U.S. market. A re-inspection of a key Sun facility in Halol, India last year led to nine new observations which could further hamstring the company despite a yearlong remediation effort at the site.
Sun Pharma inherited a number of GMP compliance issues with its 2015 acquisition of Ranbaxy Laboratories, but has continued to run into roadblocks with the FDA.
The company, Indian's largest drugmaker by generic sales, had hoped to clear the 2015 warning letter on its Halol plant last year. But the re-inspection has thrown a wrench in plans to get production at that site up to speed — a significant blow, if maintained, since U.S. sales account for nearly half of Sun's annual revenue.
Some good news did arrive in March, when the FDA lifted an import ban on Sun's Mohali plant which had been in place since 2013. Removal of the ban should clear the way for Sun to ship products for the U.S. market from the Mohali site.
But the Form 483 issued to the Dadra unit slows Sun's regulatory momentum, adding a new headache.
The letter itself is not yet public, although Bloomberg obtained a copy under the Freedom of Information Act.
Form 483s are generally issued to manufacturers after an inspection has uncovered potential violations of the Food, Drug and Cosmetic Act. Recipients are asked to respond with a corrective action plan. Failure to do so or properly address the observations can lead to an official warning letter.