US FDA makes observation on Lupin's Aurangabad plant

Lupin

Pharmaceutical major Lupin was issued form 483 by the United States Foods and Drugs Administration (US FDA) on Friday with one observation for the firm’s Aurangabad facility, according to an exchange filing.

The FDA inspected the facility between March 6 and 15.

“We are confident of addressing the concern raised by the US FDA and will resolve the same at the earliest. We uphold quality and compliance with utmost importance and are committed to comply with CGMP quality standards across all our facilities,” the company said in a filing to the exchanges.

Lupin is an India multinational company based in Mumbai. It was founded in 1968 by Dr Desh Bandhu Gupta.

When is Form 483 issued?

According to the US FDA, Form 483 is issued after the conclusion of an inspection when investigators observe that there has been a violation of the Food Drug and Cosmetic (FD&C) Act and related Acts of the US.

Observations are made when in the investigator’s judgment, practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared under conditions whereby it may become adulterated or rendered injurious to health.