Sun Pharma Lands 483 As GMP Deficiencies Continue to Plague Facility

Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483.

The agency said Sun Pharma had also not filed Field Alert Reports to district FDA offices within three days of receiving notice of bacterial contamination and significant chemical, physical, or other, deteriorations in their drugs as required.  The FDA noted six specific instances when reports were not submitted promptly for the antidepressant and smoking cessation drug bupropion.

No assessments confirmed the accuracy of dissolution tests or data, the FDA said. Validation dissolution tests for drugs include studies of specificity, selectivity, precision, intermediate precision and range, but these specific evaluations of method accuracy were not performed. Additionally, testing programs were not well-designed to assess the stability of drug product and controls were not put in place to safeguard manufacturing documents from unauthorized personnel.