New food safety law addresses product traceability The US Food and Drug Administration, is charged with developing a food traceability system to quickly track and trace foods as they move through the supply chain. Food Safety Modernization Act (FSMA) contains provisions that expand the a... K ...
WARNING LETTERCMS 535005December 19, 2017VIA UPS NEXT DAY AIRPaul F. Devine, CEOPresidentC.O. Truxton, Inc.136 Harding A
Your distribution system was deficient in that it could not differentiate between the lot number your firm assigns and the lot number assigned by the manufacturer, and therefore there is no product traceability if a recall is required. Our investigator observed that neither your receiving or ...
On October 1, 2009, FDA filed a motion to dismiss Winston’s law suit on the basis that FDA’s decision is consistent with the plain language of the statute (Chevron step one) and, even if the language of the statute is ambiguous, FDA’s decision should be afforded deference since it ...
The US Food and Drug Administration (FDA) has amended the law on chemicals commonly found in plastic food packaging and food contact applications. © AdobeStock/JHVEPhoto Phthalates are common chemicals that are found in plastic-based products such as food packaging and food contact applications....
“We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain.” The DSCSA in fact dates back to 2013, when it — an act that “outlines steps to build an electronic, inte...
• Traceability between test evidence and all requirements; • Change control SOP and supporting change request/change control records to ensure that the system continues to operate as expected; • Training SOP and supporting training records to support staff qualifications regarding system development...
Documentation of changes made during development provide traceability which can later be used to pinpoint solutions to future problems. The products end use should be a determining factor in the development of product (and component) characteristics and specifications. All pertinent aspects of the ...
Inadequate controls over materials used in aseptic processing area 无菌加工区域 中所用物料控制不足 There was a lack of traceability over the (b)(4) wipes, which are used in the aseptic processing cleanroom with disinfectant to wipe equipment surfaces. The (b)(4) certificate you provided to ...
DSCSA governs the pharmaceutical serialization requirements to increase traceability of medications in the U.S. market and aims to protect consumers by eliminating counterfeit drugs and identify product diversion. Counterfeit drugs have a significant cost impact on the pharmaceutical supply chain, leading ...