2017 Recap: FDA Warning Letter Observations and Trends
In 2017, the FDA released 476 warning letters. Top FDA warning letter violations were (1) adulterated products, (2) misbranded products, (3) insanitary conditions and (4) unapproved new [...]
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TAG: Quality Management Software
By AssurX
Posted How to Leverage an eQMS for Managing Product Adulteration
Recent FDA warning letters indicate that many drug manufacturers do not have manufacturing in a state of cGMP control. In the first half of 2017, the FDA cited adulterated products and [...]
Leveraging a Quality Management System to Do More
What provides more value in a quality management software purchase—a single use system, or one that can be leveraged for multiple purposes? This seems like an obvious answer, except that few [...]
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