Medicom Consulting

SIMULATED ( MOCK ) FDA QSIT INSPECTION SERVICE DESCRIPTION

We can provide a simulated or mock FDA QSIT inspection at your facility to determine the level of compliance of your quality management system with FDA’s Quality System Regulation 21 CFR Part 820.

This normally requires four (4) days onsite inspecting the adequacy of the sub-systems in the same manner as FDA would, and one (1) day for final report writing. A detailed exit meeting is provided on the afternoon of the fourth day, with our final report generally being provided within five (5) working days after completion of the inspection.

The mock FDA QSIT inspection benefits the company in that it provides personnel with a real experience of how an FDA inspection will take place and our report containing inspection findings will help you improve the adequacy of the sub-systems so that the identified problems do not arise during a real FDA inspection.

Our report will detail all observations of nonconformity found during the inspection, with attribution to the clause of the QS Regulation not complied with, including an evaluation of how individual observations would be viewed by FDA management, and what would likely be the overall conclusion on compliance status.

Many valuable lessons will be learned in how to prepare for and manage an inspection by FDA, ensuring your company reduces the potential for the issuance of damaging FDA Form 483’s and associated Warning Letters that can seriously disrupt business and profitability.

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