we challenged container locations of several raw materials, which returned the result “does not exist” in the SAP database, despite its confirmed physical presence in the warehouse. Note that all dispensing of raw materials is per...
Of course, if you want instant access to nearly any recent 483 (or 483R or EIR), you can get it through theRedica Systems Document Store(formerly fdazilla.com) or by having your life sciences company become a Redica Systems subscriber. Subscribers can access these enforcement documents, plus...
Unparalleled access to the vast 483 database, exceeding even what the FDA offers Advanced analyticslike trend reports and easily navigable labels Over 1,400 FDA Investigator profileswith 483, Warning letter issuance rate trends and insights
Implementation Services : MasterControl works with each company's IT department to deploy the implementation phase, which includes database configuration, installation, and configuration. Product Training Services : MasterControl's Professional Services team, consisting of former FDA experts, ISO auditors,...
The FDA decided to audit this contract manufacturer for QSR compliance. The audit resulted in the company receiving a very extensive 483 (the list of observations that the investigator finds during the inspection that are in violation with the QSR regulations). This 483 resulted in the company be...
but a number of these items translate into further quality-related costs to the company. Examples of the latter include, but are not necessarily limited to, taking the time to respond to observations or even worse yet, an FDA-483 or a Warning Letter. We think the point we are trying to...
483 is unusual because all seven observations address, for example:Apparent lack of complete data...
Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies...
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By company size Enterprises Small and medium teams Startups Nonprofits By use case DevSecOps DevOps CI/CD View all use cases By industry Healthcare Financial services Manufacturing Government View all industries View all solutions Resources Topics AI DevOps Security Software Develo...