Publications

Inspection Monitor

Welcome to the Inspection Monitor homepage, the only newsletter with the strategic information you need about FDA inspections, including what FDA inspectors are really looking for, how companies are responding to 483 and EIR citations, which companies are targeted for enforcement proceedings and who's making FOIA requests for FDA 483s and EIRs.

Each subscriber has access and receives a discount to the exclusive RECORD-RETRIEVE service, where they can order copies of 483s, EIRs and company responses, quickly, cheaply and anonymously.

The important information found in Inspection Monitor will enable you to look at your operation from the inspector's point of view. In addition to letting you know what the inspectors find wrong, Inspection Monitor tells you what happens on follow-up visits.

These revealing reports make it easy to:

  • Spot vulnerable points in validation, software and documentation
  • Tighten up quality assurance
  • Beef up training for GMP compliance and inspection protocols
  • Convince higher-ups that these changes are worthwhile
  • Avoid trouble through easy-to-use 483 citation checklists

"Inspection Monitor is valuable to executives in compliance and regulatory affairs because it gives detailed information about interesting compliance issues in all FDA—regulated activities. It provides a window on compliance in other parts of the industry, allowing us to understand where FDA is focusing."

- Blood Biologics Consultant

 

Inspection Monitor is especially useful for manufacturers and distributors of human drugs andmedical devices, blood and biologics, blood banks, their QA and RA professionals and consultants, plus attorneys.

Click to order online

 

Call 703.779.8777 or EMAIL US with any questions.

Click here to visit FDADocuments.org to place your order