U.S. FDA Found Testing, Reporting Shortfalls at Sun Pharma Plant

  • New issues may delay end of sanctions blocking U.S. launches
  • FDA will account for Sun’s responses before final decision

U.S. Food and Drug Administration inspectors in a recent visit to Sun Pharmaceutical Industries Ltd.’s plant in Halol, India, found that some testing programs weren’t adequately designed, and that failing results and potential contamination weren’t always reported in time.

Certain reports weren’t submitted to the agency within three working days on information "concerning bacteriological contamination and significant chemical, physical or other change or deterioration in a distributed drug product," FDA inspectors noted in one observation in the Halol report. The inspection concluded Dec. 1, according to the report, called a Form 483, obtained by Bloomberg News through a Freedom of Information request.

Sun’s Halol plant received a warning letter last year from the regulator due to past violations, which has prevented new product launches from the facility in the U.S., where Sun gets about half its sales. That has slowed revenue growth at India’s largest drug maker and imposed new costs to bring the plant back up to standard. The latest criticisms of Halol come after Sun invited the agency back to review a year’s worth of remediation efforts in the hopes the warning letter would be lifted.

Sun received the results of the FDA’s inspection and planned to respond within 15 days, it said in a regulatory filing Dec. 8. The company said it intends to promptly implement any "corrective" action needed and cooperate with the regulator. None of the observations were characterized by U.S. FDA as “repeat” observations, Sun said last week.

Frederick Castro, a spokesman for Sun, couldn’t immediately be reached. Sun has been able to ship older products made in the plant to the U.S.

The latest Form 483 found that testing programs weren’t adequately designed to assess “stability” of drug products. Stability tests are usually used as indicators of how the quality of a drug holds up over time and responds to environmental changes such as temperature or humidity.

The FDA’s website says that a Form 483 is issued to a company when inspectors note any conditions that may constitute violations of the Food Drug and Cosmetic Act. The agency also says that the report does not constitute a final decision of whether any regulations were violated.

The FDA considers company responses and other documents before deciding what further action, if any, is appropriate after a Form 483 like the one Sun received after the Dec. 1 inspection.

— With assistance by Hui Li, and Ari Altstedter

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