Register Now for online training to support annual GMP refresh and FSVP.
Consulting Services
FDA style Mock Inspection (On-Site Audit)
Guidance. Mastery. Prepared.
As a former FDA investigator, this is the complete package for your FDA consulting needs! This mock audit mimics an FDA inspection/investigation. It will be the closest you can get to an FDA inspection; however, without the consequences of the publicly available FDA Form 483 - Inspectional Observations (AKA list of GMP deficiencies). Our goal is to help you be FDA-ready through effective regulatory consulting.
This GMP Mock Inspection includes a full-scope FDA surveillance inspection based on FDA training and inspection resources.
- Briefing with the executive staff
- Walk-through of the facility
- Comprehensive product review of at least two products, including all lot-related manufacturing, product, testing, and monitoring records.
- Evaluations of related Production and Process Controls, Quality, and Manufacturing Operations.
- Observation in manufacturing, including personnel and sanitation
- Document review for essential and required written procedures
We will finish with a closeout meeting with relevant staff to discuss findings, potential solutions, and corrective action plans.
Average Timing: On-site 1-2 days, desk audit and document review ~2 days, and write-up (timing is dependent on client-specific needs). Approximately one week, depending on findings and firm readiness.
How confident are you in your systems? Are they FDA-ready?