Form 483 With OAI Issued to Sun Pharma’s Dadra Plant

Stagnant liquid inside an air purification unit, hundreds of complaints on tablet counts and inadequate guidance to call centers are but a few of the litany of issues outlined in the FDA’s Form 483 levied on India-based Sun Pharmaceuticals.

A 12-day inspection with six observations at the pharma’s Dadra facility last December uncovered enough violations that the agency classified it “Official Action Indicated,” a designation that most often results in a Warning Letter from the FDA.

The 18-page Form 483 reveals that procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed and that the facility’s quality unit failed to investigate product quality complaints thoroughly.

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