Lupin has responded to a warning letter issued by the US Food and Drug Administration that identified a host of current good manufacturing practice deficiencies at its US Novel Laboratories facility in Somerset, New Jersey.
Lupin Responds To FDA Warning Letter
US Agency Criticized Novel Laboratories Facility In New Jersey
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.
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