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.

Sun Pharma had hoped that a re-inspection of the facility would lift the FDA’s ban on product approvals, but agency investigators discovered that the company had adequately reviewed and approved test procedures, among several other shortcomings.

In 2015, the FDA cited Sun Pharma for similar inadequacies at the facility in a warning letter. Specifically, agency investigators noted that the company had not developed adequate written procedures for quality tests or explained batch failures. The company had failed to maintain a sterile room for aseptic processing clean as well, the FDA said.

Separately, the agency said it is withdrawing approval of 28 ANDAs on Sun Pharma’s request because those drugs are no longer marketed.

The FDA is looking to shed light on the sometimes murky rules governing compounding  operations primarily regulated on the state level, only adhering to USP 797 Pharmaceutical Compounding — Sterile Preparations. If you want to know how these guidances might affect your company, plan on listening to Responding to Compounding Pharmacy Inspections.