Indian site for Jubilant Generics lands Form 483 for QC issues
Generics giant Jubilant has one of its manufacturing sites under the FDA’s microscope.
A 14-page inspection report from late July and early August of this year revealed six major observations at the Jubilant manufacturing site in the village of Sikanderpur Bhainswal in northern India.
The Form 483 inspection report noted that Jubilant had not reviewed failures in drug batches to determine if they had been distributed. The site also failed to investigate 25 equipment failures or errors, and it neglected to investigate alarms in the “data acquisition system.”
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