No FDA-regulated manufacturers are inspected more rigorously than API firms.
These companies’ specialized operations, and their crucial role in the drug-making process, make them frequent FDA inspection targets.
There’s a lot that can be learned from the 483s resulting from such inspections — for both the API manufacturers and for the drug and biologics makers that do business with them.
Discover what the FDA inspectors are after … and what they find … in this Form 483 compilation.
Form 483 Watch: Focus on API Manufacturers
Imagine having access to recent FDA inspection reports on API manufacturers — especially if they’re your competitors — whenever you need them.
Well, now you can. In fact, you can have immediate access to 50 recent 483s, compiled in one, easy-to-access volume, with this collection from FDAnews.
Of course, you know that a Form 483 is the FDA’s most detailed public record of inspection findings.
But, a 483 is also invaluable “inside intelligence” when you want to know what FDA inspectors have found in other companies and what they’ll look for on inspection day in your own.
Here’s just a glimpse of what you’ll discover:
Collecting and compiling these 483s is not a task to undertake on your own. You’d spend days at it (even weeks!) at a cost of thousands of dollars in fees before you’d finished. But now you can get them much more easily — and less expensively.
Simply order Form 483 Watch: Focus on API Manufacturers from FDAnews. For API or finished pharmaceutical manufacturers preparing for inspection, Form 483 Watch is a must-have reference you can’t afford to be without.Whether you work in regulatory affairs, quality control or on the factory floor, you’ll find real-life details (and read between the lines) about how the FDA does its job, what catches the inspector’s eye, and what you should do now to avoid problems experienced by other API manufacturers.
Form 483 Watch: Focus on API Manufacturers is available in PDF format for $377.
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