As posted on FDA’s website. U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions.
According to the complaint for permanent injunction, Isomeric manufactured and distributed purportedly sterile drug products, including injectable and ophthalmic drugs that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. The complaint also alleges that Isomeric manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.
“Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We will continue taking strong enforcement actions against compounders who violate the Drug Quality and Security Act and put patients at risk by failing to produce sterile drugs in compliance with the law.”
FDA’s post provides links to prior inspections of this registered outsourcing facility. A 483 was issued August 2015, a second 483 issued June 2016, a warning letter posted Dec 2016, followed by a third 483 issued March 2017.
In the March 2017 483, Observation 2 identifies that 33 customer complaints were received since the previous inspection yet NONE were investigated.
- 11-complaints were related to infection, pain, swelling or knotting at the injection site.
- 6-complaints from clumping in the finished product.
- 5-complaints associated with particles, fragments, or coring.
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