Will your acceptance activities pass an FDA inspection?
For device warning letters in 2012, acceptance activities, 820.80, was the fourth most frequently cited QSR section. Don’t be among the companies who will be cited this year.
Don’t risk legal fees, delays and lost time. Get this new FDAnews management report — Regulatory Challenges of Device Acceptance — and help your organization quickly acquire a full understanding of all the relevant FDA regulations.
Acceptance activities were among the top warning letter citations in 2012, but too many companies gloss over acceptance activities details and get tripped up during an inspection. FDAnews presents an acceptance activities compliance plan that will substantially improve your ability to pass inspections.
Your team will understand:
Why You Need this Report
The FDA requires devicemakers to implement acceptance activities when raw materials arrives, before finished product is shipped and at key points during the manufacturing process if components must be verified before use. In 2012, more than 100 companies were cited in 483s for inadequate acceptance activities. And in recent years, inadequate acceptance activities have played a key role in several high-profile recalls and warning letters.
This comprehensive report reviews recent FDA warning letters citing acceptance activities to provide a clear understanding of what went wrong and how companies can avoid these problems. Get the report to learn about:
Ideal for All Devicemaker Teams
Those who will benefit from this report include purchasing managers, suppliers, QSR managers, product testers, plant inspection managers and all personnel involved in manufacturing, packaging, labeling, installing and servicing devices as well as training.
Regulatory Challenges of Device Acceptance is available in print or PDF format for only $397. The low price includes sampling plans, warning letter samples, FAQs and more.
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Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.
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