Form 483 cites Lupin manufacturing site in India for contamination and other quality control observations
The FDA has had its eye on the pharmaceutical manufacturer Lupin for a while, and now another facility for the company has been inspected by the US regulators and has revealed several quality control issues.
According to the FDA’s 483 inspection report, conducted from Oct.3 to Oct. 14 of this year, the facility that was inspected was a Lupin manufacturing site in Pune, India, which according to the company, develops biosimilars for the global market. The 10-page inspection report had a total of 18 observations.
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