Lupin Slapped With Fresh FDA Warning Letter
Lupin has announced that the US FDA has slapped its Mandideep plant in central India with a warning letter after the company failed to fix compliance problems detected by inspectors in late 2018.
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Lupin has named a new head of compliance, emphasizing the importance of achieving the highest quality standards just weeks after the FDA notified the firm of observations following an inspection at its Indian facility in Tarapur.
Lupin says it is rebuilding its reputation for quality and compliance after the US FDA awarded VAI status to a manufacturing facility in Goa that was hit by a warning letter back in 2017.
Lupin insists it has a “comprehensive remediation plan” to address deficiencies identified at its Novel Laboratories facility in New Jersey by an FDA warning letter. The Indian company says it does not anticipate any near-term commercial impact or supply disruptions linked to the letter.