Sun Pharmaceutical said it has received four observations from the U.S. FDA for its Halol facility in Gujarat.
The agency conducted a pre-approval inspection (PAl) of the company's western India facility from June 3- 11, which concluded with a Form 488 with four observations. Observations included not following the aseptic process validation master plan during media fill runs, failing to properly handle analytical testing data, failing to establish design plans that describe the design and development activities and failing to validate certain processes.
It was just last June that the drugmaker's Halol factory finally had supply restrictions imposed on it by the FDA lifted. Restrictions to certain drugs were made at the particular site after the FDA inspection found quality control failures.
Sun Pharma said it is committed to addressing the new observations promptly.
Read the FDA report.