FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Compounder Hit With Consent Decree Over Insanitary Production Conditions

Feb. 14, 2019

A federal court entered a consent decree against a Pennsylvania compounder for manufacturing purportedly sterile drugs in insanitary conditions.

The FDA complaint filed with the consent decree claims Jeanette, Pennsylvania-based Ranier’s Rx Laboratory manufactured and distributed drug products it represented as sterile, including injectables for erectile dysfunction and ophthalmic drugs for use as antibiotics, cataract therapies and anesthetics that were manufactured under insanitary conditions.

The decree, issued by the U.S. District Court for the Western District of Pennsylvania, restricts Ranier’s and its owner, pharmacist Francis H. Ranier, from manufacturing, holding or distributing sterile drugs compounded at the facility until it complies with the Food, Drug & Cosmetic Act.

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