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Isomeric Enters Drug GMP Consent Decree As FDA's Crackdown On Drug Compounders Continues

 
• By Joanne S. Eglovitch

Drug compounding pharmacy Isomeric has entered a consent decree after turning a blind eye to a multitude of GMP problems with its injectable and ophthalmic drugs. This brings to six the number of consent decrees the Justice Department has reached with compounding pharmacies since the New England Compounding Center tragedy in 2012.

Glass Mortar and Pestle

Isomeric Pharmacy Solutions LLC Aug. 4 entered a consent decree with the Justice Department after failing to correct numerous GMP problems with injectable and ophthalmic drugs that FDA had identified in earlier inspections as the agency continues to flex its enforcement muscle against drug compounding pharmacies.

Problems ranged from inadequate environmental monitoring to failing to resolve customer complaints and an overall failure to investigate or take corrective actions to address unsanitary conditions that caused the presence...

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