The USFDA had conducted inspection of this facility during May 30 to June 5.
Natco Pharma shares slipped 2 percent on June 25 after availability of detailed observations by the US health regulator for Kothur plant.
Earlier this month, the US Food and Drug Administration had issued Form 483 with nine observations for company's formulation facility at Kothur, which are now available in the public domain.Here are these nine observations in detail:
> Responsibilities and procedures for quality control unit are not fully followed
> Written procedures are not followed for evaluations conducted
> Probe records in discrepancies don't include follow-up, conclusion
> Lab controls don't include scientifically sound and appropriate test procedures
> Deviations from written lab mechanisms are not justified
> Lab records are deficient
> Master production and control records are deficient
> Routine calibration of mechanical equipment is not performed
> Records of calibration checks of auto, mechanical, electronic equipment are not maintained
The USFDA had inspected this facility from May 30 to June 5.
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