Form 483 action looms over Sun’s Halol plant – dnaindia.com
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The recent US Food and Drug Administration (FDA) surprise visit at Sun Pharmaceutical Industries’s Halol facility may lead to an issuance of Form 483, potentially a precursor to an import alert.
The US FDA last week conducted a surprise inspection at company’s Halol facility in Gujarat, which contributes nearly 15-20% to Sun Pharma’s US sales. Recalls of various drugs made at the unit was seen as a trigger for the inspection.
According to an industry expert, US FDA now has its office in India and a surprise inspection in any facility of any pharma company is therefore a possibility now. The whole motive is to check whether these companies are maintaining the manufacturing and quality standards as laid out by the FDA, the expert said.
FDA issues Form 483 to a company at the conclusion of inspection in which the investigators observe conditions that they think violate the Food Drug and Cosmetic Act and related Acts. Form 483 notifies the company of objectionable conditions.
The company is encouraged to respond with a corrective action plan followed by its implementation. Else, an import alert could be issued against the company…
Read more – dnaindia.com