FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Vials Test Positive for Bacteria; Amniotic Censured for Sterility Controls

Sept. 7, 2016

Vials of a U.S. drugmaker’s product tested positive for bacteria, underscoring the company’s lack of sterility controls, the FDA says.

An inspection of an Amniotic Therapies facility found the company lacked procedures to prevent microbiological contamination of biological drug products, according to an FDA warning letter released Tuesday.

The FDA highlights the company’s failure to test the sterility of its products, which were linked to four adverse events, including two infections from Mycoplasma hominis, and positive tests for M. hominis.

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