Sun Pharma May Ask for USFDA Re-Inspection Following GMP Remediation Efforts

Feb. 16, 2016

Sun Pharmaceutical Industries may ask the United States Food and Drug Administration (USFDA) to re-inspect its Halol facility in Gujarat, India, in the first quarter of the next fiscal year, reports DNA India.

The report adds that the company is currently undertaking remediation measures to make the plant compliant with good manufacturing practice (GMP) norms.

A warning letter was previously sent by the FDA to the Halol facility in December 2015. It mentioned its inspectors had "identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals." The FDA also found that Sun Pharma "failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by the authorized personnel."

Significant violations included the company's failure "to maintain floors, walls and ceilings of smooth, hard surfaces that are easily cleanable in aseptic processing areas."

To learn more, click here to read the full article from DNA India.