FDA issues Form 483 to Lupin Somerset NJ facility
Business
Lupin's Somerset, New Jersey, facility just got a Form 483 from the US Food and Drug Administration after an inspection this week.
The notice points out three areas where the plant may not fully meet US drug safety rules, and asks Lupin to fix these issues.
Lupin pledges FDA response and compliance
Lupin says it's taking the feedback seriously and will respond to the USFDA within the stipulated timeframe.
The company also emphasized its commitment to keeping up with top manufacturing standards and making sure its operations stay in line with regulations.