Despite Import Alert, Sun Still Aims To Remediate Halol Rather Than Transfer Products
A difficult US FDA inspection on the eve of the COVID-19 pandemic left Sun’s Halol plant barred from launching additional drug products until the FDA could reinspect it. But the reinspection provided no relief and a later import alert bars most of the plant’s drug products from the US market. Some are asking why the firm is not transferring products to other facilities.
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Halol Plant Approvals Still On Hold As Sun Responds To Lengthy FDA Inspection Report
After years of pandemic-related delays, US FDA reinspects key Sun plant in Halol, India, hit with “official action indicated” inspection findings that tabled approvals just before COVID-19 impeded travel. However, new findings are generating further discussions.
The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.
How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution
Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.