Radiation-Emitting Products

Independent Audit Inspections and Joint Inspections

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When you download a facility for an inspection, you have to designate the type of inspection as one of the following:

‘A’ for Annual,

‘F’ for Follow-up,

‘I’ for Independent audit, or

‘H’ for Headquarters initiated.

Types ‘F,’ ‘I,’ or ‘H’ should be used only by FDA MQSA inspectors.

Type ‘I’ should be used only by MQSA auditors.

Once you designate an inspection as a Type ‘A’ during the downloading procedure, it will appear on your laptop screen 3.1/inspection as such. In this screen, you need to designate the type of annual inspection you will be conducting; you may choose "Basic" (for a routine annual inspection), "Joint Audit (J)" (for when you are accompanied by an MQSA auditor), or "Mentored" (for when you are accompanied by another inspector acting as your mentor).

FDA MQSA auditors who are FDA-certified MQSA inspectors are required to accompany other inspectors on some annual inspections. However, only when a designated FDA MQSA auditor accompanies you on an inspection for the purpose of an audit should you enter the "J" value under the "Annual Inspection Type" field. Additionally, only under very unusual circumstances would an independent audit inspection be conducted and then only by a designated FDA MQSA auditor.


Page Last Updated: 07/24/2014
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