Data Integrity Lapses Continue To Erode Wockhardt
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.
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Regulatory uncertainty could imperil the crop of emerging companies making a go of it in the incentive-laden US anti-infective space.
Against a backdrop of heightened regulatory scrutiny of manufacturing sites and processes, the heads of five top Indian firms told a recent forum in Mumbai how they are “rebooting” quality compliance and culture within their organizations. Tangible and intangible results are beginning to show but there is a long road ahead.
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.