US FDA Form 483 and Warning Letter Analysis

FDA form 483 is officially known as Notice of Inspectional Observations. Organizations that act in non-conformity or violate GMP regulation/quality system are issued the FDA 483 warning Letter(s) by FDA investigators. Responding to FDA 483 warning Letter(s) deserves caution. A action plan describing the specific timeframe of CAPA and implementation is extremely important. Medical device or IVD manufacturers will always want to avoid Form 483 or Warning Letter from the US Food and Drug Administration (FDA). Handling and responding to Form 483 is key in preventing a warning letter from the FDA. As part of our services, E & E Medicals and consulting shall help in responding to FDA 483 Observations and FDA Warning Letter through the following steps:

  • Reviewing the 483 observations or warning letter
  • Analyzing and Identifying Corrective Actions
  • Assisting in planning and implementing Corrective Actions
  • Writing a professional 483 Response within 15 business days

Product Recalls and Market Withdrawal

Many medical device manufacturers risk product corrections and removals (Recalls). These recalls have an impact on the brand and leave the patients at risk. Poorly managed recall procedures can result in devastating consequences with the FDA. E & E Medicals and consulting offers a recall consulting service that will resolve your recall problems promptly in the following ways: