An Ipca Laboratories plant savaged in an FDA warning letter three years ago continues to fail manufacturing standards that would assure its drugs are safe and effective. The FDA says that is “demonstrated by a cascade of failure” in the quality unit of the Indian plant.
These failures at the finished products plant in Silvassa are detailed (PDF) in an FDA Form 483 that followed an inspection last month. There are only three observations, but the list of issues stretches to 10 pages.
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It says the plant quality unit allows batches to be released for use without properly reviewing out-of-specification and out-of-trend investigations, routine quality control (QC) testing worksheets or electronic data to ensure they meet standards.
It says some corrective actions on change of controls were open for two years while analysts have not properly followed dissolution testing procedures for more than a decade.
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The FDA has been down this road with Ipca before. The Silvassa plant was one of three that was slammed in a warning letter in 2016 for serious data manipulation and falsification. The FDA said the problem was rampant at that company, enforced by senior managers in the QC unit to keep product supply flowing.
Ipca has told the FDA in the past that it will get the problems under control, and the problems have not kept it from expanding in the U.S. Last year, it paid nearly $10 million for Pisgah Labs, an API maker based in Pisgah Forest, North Carolina.