FDA Takes Action Banning Imports From 4 Indian and Chinese Firms Under GDUFA’s User Fee Provisions

The FDA on Wednesday banned imports from Chinese and Indian generic drug companies because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 (GDUFA), otherwsie known as the “Red List”.

The companies include China’s Jiangsu ZW Pharmaceuticals Co. Ltd., which received a warning letter in 2015, and Wuxi Kaili Pharmaceutical Company, which also received a warning letter in 2015, as well as India-based Fleming Laboratories, which received a warning letter in 2014, and Sharon Bio-Medicine Limited, which received a warning letter in 2015.

Additionally, Section 502(aa) of the Federal Food, Drug, and Cosmetic Act provides that any drug or active pharmaceutical ingredient manufactured, prepared, propagated, compounded or processed in a facility for which the required fees have not been paid or required self-identifying information has not been submitted, are deemed to be misbranded and may be subject to refusal of admission to the US.

How does FDA decide to add firms or products to the red list or exclude firms or products from the green list of an existing import alert?

Each import alert describes the conditions that may result in the firm being subject to DWPE. When a
product and/or firm is violative and meets the criteria indicated in an import alert, it will be added to the red list or removed from the green list of the alert.
The following are some reasons your product or firm may be subject to DWPE. This list is not all inclusive.

  • FDA has sampled your product and it tested violative for a pathogen
  • FDA has sampled your product and it contains illegal colors or food additives
  • Your product contains pesticides that are not allowed or do not meet tolerance levels
  • The firm has not provided sufficient evidence to support adding them to the green list
  • Your product is an unapproved new drug
  • The foreign firm had a violative inspection by FDA
  • The foreign firm has refused inspection by FDA

What is a red, green and yellow list?

Type of List Description Example
Red List Firms, products and/or countries are subject to Detention without Physical Examination (DWPE) under the Import Alert. EXAMPLE:  A food that previously was shown to contain deadly bacteria that can cause a food-borne illness.
Green List Firms, products and/or countries that have met criteria for exemption from Detention without Physical Examination (DWPE) under the Import Alert. EXAMPLE:  Import Alert 12-03 indicates that all soft cheeses from France are subject to DWPE. However, there are some soft cheeses from firms that received an exemption based on the guidance in the import alert. The firms/ products that are allowed to be imported are on the green list of this import alert.
Yellow List Firms, products and/or countries subject to intensified surveillance; or firms that may have satisfied GMP issues but where the nature of violations may warrant further field examinations of individual entries and/or additional analyses. EXAMPLE:  Import Alert 66-38 indicates that Skin Care Products Labeled As Anti-Aging Creams are subject to DWPE. This alert includes a red list and a yellow list.
All entries of skin care products imported by the firms or manufactured/shipped by the firms on the Yellow List will continue to be checked for drug claims until the FDA has confidence the firm’s products are in compliance.