HQ Team
December 8, 2022: Indian drugmaker Sun Pharmaceutical Industries, facility in western Gujarat state, has been listed by the Food & Drug Administration under “import alert,” according to a BSE filing.
The US regulator inspected the company’s Halal facility from April 26 to May 9 this year. It was not clear whether FDA asked the company to take remedial actions or which drugs were put on alert.
All future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with FDA’s Current Good Manufacturing Practice standards.
The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing a drug product.
Product safety
The regulations ensure that a product is safe for use and has the ingredients and strength it claims to have.
The FDA has excluded 14 products from this import alert subject to certain conditions, the filing stated.
For the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3% of the company’s consolidated revenues, including the 14 excluded products.
“The company continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the Company’s remedial action.”
An import alert prevents potentially violative products from being distributed in the US. It puts the responsibility back on the importer to ensure that the products imported into the US comply with the FDA’s laws and regulations.
