What are FDA import alerts?

Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations.

What is wrong with Sun Pharma?

That warning cited several problems at Sun’s Karkhadi, Gujarat facility including deficient cGMP manufacturing practices for both APIs and finished drug products sold in the US. “These violations and deviations cause your drug products and APIs to be adulterated,” said the FDA.

Is Sun Pharma listed in US?

Sun Pharma is present in the U.S. through its legal entities and its subsidiary, Taro Pharmaceuticals. Sun Pharma is the fourth largest global specialty generic pharmaceutical company in the world, with revenues of over US$ 4.5 billion.

What is FDA green list?

A Green List is a list of companies that are exempt from a particular Country-Wide Import Alert. Following the example above, shrimp exported by an Indian company that is on the Green List is not subject to DWPE.

What is FDA red list?

The Red List identifies firm(s) that have offered FDA-regulated articles for import into the United States and yet refused to allow the completion of an FDA inspection of their foreign establishment(s) for the purpose of determining establishment conditions and compliance with applicable laws and regulations, for …

Is Sun Pharma reputable?

Very good company to work.

Where did FDA ban imports from Sun Pharma?

MUMBAI (Reuters) – The U.S. Food and Drug Administration (FDA) has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries Ltd’s plant at Karkhadi in the western state of Gujarat, in the latest quality blow for India’s drug sector.

Can a product be removed from an import alert?

For information on how to be removed from an import alert, please see the import alert removal page. Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations.

How is an import alert sent to the FDA?

The firm has not provided sufficient evidence to support adding them to the green list Violation information and recommendations for placement on import alert are forwarded to the FDA’s Division of Import Operations (DIO) and, when applicable, the relevant Center office.

What does the import alert number start with?

Import Alert #. This is the number issued by the FDA. The first 2 numbers are the industry code of the product. For example, any import alert that starts with a 16 will be related to seafood.