FDA 483 Responses and Remediation

Microrite has been instrumental in responding to regulatory observations as well as implementing achievable remedial actions that eliminate patient risk and can prevent future regulatory scrutiny. When addressing responses to any 483 observations from the FDA; Microrite’s team of former FDA consultants as well as technical experts in the areas of cleanroom, microbiology, sterilization, validation and quality cohesively assess the impact of each 483 on patient safety. We ensure adherence to current regulatory expectations as well pertinent and current standards, guidances and requirements. The added advantage of utilizing Microrite’s team is that our consultants serve on the board or are expert committee members of industry organizations such as ASHRAE, ISO, AAMI, IEST, USP and IP. This allows us to review gaps from facility design to product testing.

Steps for remediating regulatory observations do not entail only generating and closing CAPAs (corrective and preventive action). It is imperative to understand the underlying issues which were the cause of receiving 483 observations in the first place. As a team we excel at evaluating compliance gaps holistically from a regulatory, scientific and technical perspective and providing practical remediation plans to eliminate risk.
Let our expert team be your partners in:
• Expert responses to 483 observations
• Review of responses from a compliance and technical perspective
• Implementing corrective and preventive action (CAPA) programs with scientific merit utilizing a holistic approach
• Conducting internal audits and gap analyses
• Development, execution, monitoring, and project management of the remediation plan
• Conducting training and qualification of your personnel
• Optimizing quality risk management programs