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 ...

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 ...

Recent warning letters have shed light on common mistakes companies make when responding to 483 findings. Here are a few best practices for addressing FDA’s concerns and mitigating the risk of further ...

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 ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

Dr Reddy's Laboratories receives US FDA Form 483 with five observations at Srikakulam facility; company to address issues within timeline.

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 ...

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 ...

Lies, shredded documents and a trashcan dowsed in acid: Intas Pharmaceuticals’ new write-up from the FDA is a textbook example of what not to do when investigators come knocking. It also offers a ...