Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments

November 15, 2019
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Solutions to 21 CFR Part 111 Challenges
Solutions to 21 CFR Part 111 Challenges

The rapidly-growing nutraceutical industry is moving into an era of increased government oversight and tigh...

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21 CFR Part 11 Risk of Non-compliance
21 CFR Part 11 Risk of Non-compliance

This white paper delineates FDA’s expectations and current thinking on 21 CFR Part 11 according to its 2003...