FDA reinspection of Sun’s troubled Halol plant said to be underway

Sun Pharmaceutical's Halol facility in India.

The FDA reinspection of Sun Pharmaceutical’s troubled Halol plant in India is reported to be underway, as the drug manufacturing site is seen as a critical revenue stream for the company.

The regulatory agency inspection, which Sun requested earlier this year, began last week, The Economic Times reported, citing three unnamed sources.

Last year, the FDA slapped the facility with a warning letter after a previous inspection that listed 20 critical observations at the operations of the plant.


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Sun Pharma declined to comment to the publication on reports of the latest inspection.

The Halol site is viewed by Sun as a critical element in the company’s goals to increase its growth in the U.S. market. The Halol facility, which produces a gamut of products from tablets to nasal sprays, accounts for an estimated 15% of the company’s revenues in the U.S.

In July, the FDA said Sun had begun recalling 16,085 bottles of the antidepressant bupropion hydrochloride extended-release tablets manufactured at the Halol plant because they failed specifications for dissolution. The recall was initiated in June.

Sun saw sales slip after the U.S. regulatory agency cited the Halol plant with a Form 483 in December 2014. The agency issued a warning letter at that time for a number of quality and data-integrity issues, and the drugmaker recalled a number of products as a result.

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