Sun Pharmaceuticals Gets Another Form 483 for Continued Manufacturing Lapses

In a notice to India’s stock exchange, Sun Pharmaceuticals reported that the FDA conducted an inspection of its Gujarat, India, facility in April and early May and issued a Form 483 inspection report with 10-observations.

The company did not offer details of the deficiencies, but the facility has a history of quality problems observed during previous inspections. The FDA issued an 8-observation Form 483 after a December 2019 inspection and a 6-observation Form 483 following an inspection in August 2018.

The company said it plans to address the new observations promptly and will work closely with the FDA to enhance its good manufacturing practice compliance on an ongoing basis.