One regulatory inspection was reported. It was a routine FDA inspection of a Sponsor/Manufacturer. Two days notice was given. The inspection lasted four days and was conducted by one inspector.

The inspector focused on the facility's statistical sampling plans, the justification for the statistical plan, and the rationale behind their validation plans.

The advise offered was that if you treat them like the enemy, that will become a self-fulfilling prophecy.

A PRCSQA member involved in recent EPA inspections indicated that EPA's current format for inspecting is to send one inspector. The inspection lasts from one and a half to two days which then allows the inspector to conduct two inspections per week.

If you have had a recent inspection, please send your inspection experiences to Sherita Normington. FAX (916) 481-2959 or telephone (916) 481-3141. The questionnaire is included in your newsletter, or can be found online.

Directions for printing out the online form:
Clicking on the link below will open a new browser window. Please print out the form and then close your extra browser window. This will return you to your original browser automatically. Thank you! Inspection Experience Form