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Lupin gets Form 483 for Pune's biotech facility

Lupin gets Form 483 for Pune's biotech facility

Lupin has informed that the US FDA conducted a prior-approval inspection at the company's biotech manufacturing facility in Pune. 

The inspection concluded with the issuance of Form 483 with seventeen observations. "We are committed to addressing the concerns raised by the US FDA expeditiously", the company said in a filing.

 It further added, "the company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility."
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Lupin Pharma US FDA
More news about: quality / gmp | Published by Sudeep Soparkar | October - 21 - 2022 | 404

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