The Associated Press and several major news outlets reported that Caraco Pharmaceutical Laboratories announced on Tuesday that it has agreed to a series of measures with the FDA that will allow the company to resume manufacturing operations.
As reported on Secure Pharma Chain Blog, Caraco has had their manufacturing operations halted by the FDA after they found repeated violations of manufacturing standards and seized inventories. Recalls have been made on certain Caraco products that were found to have manufacturing defects, including oversized tablets and possible formulation errors.
The manufacturing restrictions will be in place until regulators give written notification of compliance with the agreement measures and regulations. Caraco will continue to distribute FDA-approved products manufactured by third parties.
XStream endorses the concept that all members of the pharmaceutical supply chain utilize material screening process in all points of the process; raw materials, production, quality assurance, packaging, distribution and dispensing in order to protect the supply chain and the consumer.
To learn more about XStream’s revolutionary material screening technology visit: www.xstreamsystems.net.
As reported on Secure Pharma Chain Blog, Caraco has had their manufacturing operations halted by the FDA after they found repeated violations of manufacturing standards and seized inventories. Recalls have been made on certain Caraco products that were found to have manufacturing defects, including oversized tablets and possible formulation errors.
The manufacturing restrictions will be in place until regulators give written notification of compliance with the agreement measures and regulations. Caraco will continue to distribute FDA-approved products manufactured by third parties.
XStream endorses the concept that all members of the pharmaceutical supply chain utilize material screening process in all points of the process; raw materials, production, quality assurance, packaging, distribution and dispensing in order to protect the supply chain and the consumer.
To learn more about XStream’s revolutionary material screening technology visit: www.xstreamsystems.net.
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