Sun Pharma’s Halol plant’s leaky roof irks FDA
pharmafile | December 13, 2016 | News story | Manufacturing and Production | FDA, Sun Pharma, inspection
The FDA’s two week inspection of Sun Pharmaceutical’s Halol plant produced a 14-page report, with some criticisms reserved for poorly designed testing programs and expiration date issues. The report could come as a blow to Sun Pharma as it relies on the plant for a reported 15% of revenue generated in the US. The site was also given a warning in December of last year, highlighting issues with the same site.
The latest report found that the FDA identified nine violations, including some that are repeated from the previous report. The issues include problems in the quality control of products that are manufactured at the site. The problems also extended into the administrative side of the plant, with the report finding that: “Appropriate controls are not exercised to assure that changes to documents related to the manufacture of drug products are instituted only by authorized personnel”.
There were also issues with the site itself, with the report noting that the “FDA investigator observed buckets with water collected from ceiling leaks and other leaks in this manufacturing area.” This was an area that the FDA had previously mentioned to Sun Pharma in 2014 and had not yet been addressed two years after, on the most recent inspection.
Sun Pharma is the fifth largest producer of generic drugs in the world market, with almost half of its total revenue coming from US market with sales of $2.1 billion. Keeping on the right side of the FDA is crucial and Sun Pharma experienced the down side of inspection last year, as sales of products suffered and new products were not allowed to reach the US market. The latest inspection came after Sun Pharma invited the FDA back to the site in attempt to remediate the effects of the previous warnings upon the facility.
Ben Hargreaves
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