|Sun Pharma headquarters in Mumbai, India--Courtesy of Hemant Mishra/Mint|
Details of the FDA Form 483 that has loomed over Sun Pharma for the past two weeks have become public. Credit Suisse reports FDA inspectors made 23 observations during a recent inspection of a plant that accounts for up to 25% of Sun's sales, but the regulator found no evidence of data integrity failings.
Current reports suggest the FDA is criticizing Sun's plant in Halol, India for procedural problems, rather than the systemic data integrity issues that have blighted some of the drugmaker's peers. Aseptic practices accounted for many of the 10 observations inspectors made at the injectable unit of the Halol plant, according to local media reports covering Credit Suisse's note. The inspectors want Sun to improve how it handles contaminated vials and the general upkeep of the plant.
"The building is not in a good state of repair, including water stains with ceiling damage and water leaks from the ceiling in the personnel corridor of the injectable manufacturing area," DNA reports. Inspectors made 9 observations at the quality control laboratory and a further four at the solid dose unit. Inspectors picked the solid dose facility up on its performance of routine checks of blister packaging equipment and the lack of a corrective action plan to address two recalls.
While the observations are a negative for Sun--particularly given the importance of the plant to its business--Credit Suisse thinks the 483 could have been much worse. The financial services business said the FDA could block new product approvals, but is unlikely to impose an import alert. Sun's stock closed up 4% on the day the Credit Suisse report was published.