FDA inspection at Lupin manufacturing site uncovers breakdowns left uninvestigated and data questions
A March FDA inspection at Lupin’s manufacturing site in Pithampur, India has uncovered quality and other performance issues.
The FDA’s 13-page 483 inspection report detailed the site’s failure to document deviations or equipment failures that occurred during manufacturing and packaging. Lupin had not done investigations, risk assessments or taken any preventative actions for the breakdowns, the report said.
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