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27 Nov 2014

What is Form 483 in regulatory affairs?

Dr Reddy’s Laboratories has received inspectional observations from the US Food and Drug Administration (FDA) for one of its active pharmaceutical ingredients (APIs) manufacturing plants located in Srikakulam district of Andhra Pradesh. The observations came after a team of the US FDA visited the site recently.

The USFDA had last week conducted a surprise check on the company’s plants at Vizag and Srikakulam. The Form 483 is a list of observations that the audit inspectors find objectionable at the plant and hand it out to the management. After receiving this, the company needs to reply in writing, within 15 days, giving a detailed plan of corrective action.

Very recently, IPCA Labs had received Form 483 observations for two of their plants- at Indore and Ratlam. Cadila Healthcare too got such observation for their Moraiya plant in Gujarat. For Indian drugmakers, it is not new how the FDA has been stepping up scrutiny, as inspections of foreign facilities (outside US) doubled in 2013 against what it was in 2008.

The USFDA typically inspects facilities, for pre-approval, compliance with current good manufacturing practices, or product specific approval. The FDA’s inspection team in India has around 20 people, who carry out ‘aggressive surveillance and surprise inspections.

The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection”. Form FDA 483,“Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections.

So Form 483 observation is lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. 

A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires.

 

 

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