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Indian API maker slammed with US FDA Warning over data issues

By Dan Stanton , 25-Mar-2014
Last updated on 25-Mar-2014 at 16:40 GMT2014-03-25T16:40:10Z

Failure in maintaining test and production data has landed an Indian API maker with a Warning Letter from the US Food and Drug Administration (FDA). 

Smruthi Organics Limited received the letter earlier this month at its active pharmaceutical ingredient (API) facility in Solapur, Maharashtra, following an inspection by the FDA in October 2013.

The agency cited a number of deviations from current good manufacturing practice (CGMP), including the failure to maintain “complete and accurate laboratory test data” generated in the course of establishing compliance of APIs.

One example the inspection noted was that there was no written explanation for deletion events observed on audit trails for standalone high-performance liquid chromatography (HPLC) units, with standard operating procedures (SOPs) not including instructions for the retention of electronic raw data.

Another violation included having incomplete raw data to support the test method validation activities for the test methods used for in the firm’s APIs, whilst calibration and media preparation records were identified to not be authentic.

Furthermore, the “failure to maintain and make available for inspectional review production and control records for currently marketed APIs,” led the agency to quote a European Directorate for the Quality of Medicines (EDQM) inspection from February 2013  that found the firm was blending out-of-specification (OOS) API batches with other API batches.

“Your Head of Quality Assurance and Regulatory Affairs stated to our investigator that the relevant records had been destroyed,” the FDA said. “However, your written response [from November 4, 2013 and additionally from December] states that there was a miscommunication during our inspection and that in fact these records have not been destroyed.”

According to its website, the firm manufactures the active ingredient metformin (for oral antidiabetic drugs), Norfloxacin (a chemotherapeutic antibacterial agent) and Carbidopa (for Parkinson's disease), for both the US and EU, with a number of other APIs made for non-regulated markets.

In a statement released to the Bombay Stock Exchange , the company said it “is working with USFDA in resolving the issues.”

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