When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...
Q&A with David Elder and Richard Wright of Strategic Compliance Consulting, PAREXEL International. Both Elder and Wright formerly served with FDA. Q. How should a company approach handling an FDA-483 ...
The best approach to deal with an observation with which a company does not agree is to prevent an FDA-483 observation in the first place. The best approach to deal with an observation with which a ...
Should you ever have an FDA inspection, you’re going to want to know what to do after. And if you’re a medical device company with class II or class III products registered with FDA, you need to be ...
Dublin, July 10, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspections - Top FDA 483 Observations and Prevention Strategies" training has been added to ResearchAndMarkets.com's offering. This expanded ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...
The FDA injected a Form 483 frown into Revance Therapeutics’ plans to gain regulatory approval for its Botox rival daxibotulinumtoxinA, citing quality control and records issues at the manufacturing ...
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