The Ferer Group Consulting Services

Mock Regulatory Inspection Audits / Pre-Approval Inspection

(Quality Systems, Facilities and Equipment, Materials, Production, Packaging and Labeling, Laboratory Control Systems)

I have participated in a number of mock audits, typically following the FDA Systems Based Inspection approach. These audits provided invaluable information to my clients which enabled them to remediate deficiencies prior to an actual regulatory inspection. I was also able to help them develop corrective action plans to mitigate potential observations from the regulatory authorities.

On one of these inspections, my client was filling a clear liquid into glass ampoules. While they had correctly implemented the correct product / lot identification schemes to ensure product identity, I observed some deficiencies that we were quickly able to correct that prevented a potential mix up of unlabeled product.