The QMN Weekly Bulletin

Indian Companies Get FDA Warnings for cGMP Deviations

Aug. 23, 2013

Two Indian pharma companies — Posh Chemicals, a maker of active pharmaceutical ingredients (API), and Sentiss Pharma, a maker of finished drugs — are in hot water with the FDA, having both received warning letters in the wake of recent facility inspections.

The letters, posted August 20, detail current good manufacturing practice (cGMP) violations for both, including data falsification and poor investigations into batch failures.

The agency inspected Posh Chemicals’ Hyderabad, India, plant in March, and investigators chided the API maker for falsifying cGMP data.

The quality control chemist admitted to the FDA that he, under the direction of a senior employee, recorded “false visual examination data in the logbooks for reserved samples.” In response to the letter, the agency wants Posh to describe its investigation into the incident, including the extent of falsification and the responsibilities of the senior official.

The FDA is also asking Posh to reassess its data integrity practices at the facility. The request follows up on investigators’ findings that there were “no restrictions to access the laboratory data residing in the workstations attached to your standalone instrumentation.”

Investigators expressed concern about the potential for data to be deleted or altered, as well as about a lack of audit trails that could detect if such changes to data had occurred.

Posh is currently purchasing and updating software to handle these issues, the letter states.

Sentiss, formerly known as Promed Exports, was also warned by the FDA following a March-to-April inspection of the company’s Tehsil Nalagarh, India, plant.

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