FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Inspections and Audits

FDA Issues Warning Over Sterility Lapses at Compounding Facility

May 12, 2016
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The FDA issued a blanket warning last week to avoid drugs compounded by Medaus Pharmacy after the company refused to recall suspect products.

The warning came two days after the agency issued the company a formal recall request, asking it to recall all unexpired sterile compounds produced at its Birmingham, Ala., facility after a March inspection “raised concerns about Medaus’ ability to assure the sterility of drug products.”

Inspectors contended that the facility appeared to lack necessary air filtering, utilized improper storage of compounded products and failed to employ decontamination when personnel moved into and out of clean rooms.

 

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