Enforcement Log, Dateline 09.30.16: Pan Drugs, Zhejiang Hisoar, Wockhardt, Zhejiang Bangli, Pharmaceutics International
Pan Drugs, Zhejiang Hisoar hit with data integrity warning letters; Wockhardt, Zhejiang Bangli and three others lose US market access; Pharmaceutics International's EU access in jeopardy.
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Recent US FDA drug GMP warning letters featured findings of lax contamination controls and data integrity issues at firms in China, India, Japan, Illinois and East Texas. Meanwhile, FDA hit six plants in India and China with drug GMP import alerts.
Details in US FDA’s latest warning letter for Indian site suggest that firm’s data integrity remediation efforts are not up to scratch at least yet. Agency’s observations also highlight the potential complexities that may be on hand for Cempra’s antibiotic Solithera, recently hit by a complete response letter.
Pharmaceutics International must suspend manufacturing of commercial and investigational medicinal products largely for failure to manage cross-contamination risks appropriately, according to EU GMP non-compliance notice. Resumption of IMP production will hinge on approval of trial-by-trial risk assessments.