FDA & Internal Audits

#1
I was told that the FDA is "not permitted" to look at a med device company's Internal Audit data during an audit. I was also told that CAPAs should be split into Audit CAPA and [regular] CAPA and by doing so, the FDA is blocked from seeing all Audit CAPAs and can only view [regular] CAPA. Seems completely illogical to me, but then weirder things have happened. Any truth to the idea that FDA is blocked from Internal Audit data and Audit CAPAs?
 
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Sidney Vianna

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#2
It has been a loooooooooong time, probably 25+ years when I was auditing a small manufacturer of medical devices against ISO 9001:1994 and when I asked to delve into the records of internal audits and associated action items, the auditee went ballistic because he thought I was under the same restrictions that the FDA inspectors were under. I guess the FDA does not want their inspectors to see “skeletons in the closet” of the organization, but internal audits is such a critical aspect of a management system that, IMO, should be scrutinized by the regulators.

Actually in some industry controlled accredited schemes, credit is being given to organizations with robust internal audit programs and CB’s can reduce their audit time onsite if the registrant can demonstrate such controls against pre established criteria.
 

Tidge

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#4
Any truth to the idea that FDA is blocked from Internal Audit data and Audit CAPAs?
There is no truth to this at all. A typical paradigm (for compliant QMS) is: FDA inspectors won't ask for internal audit records themselves, but expect to (be able to) see the 100% records of all CAPA. An FDA auditor is certainly allowed to ask to see the schedule of internal audits, and records that the internal audits were done.
 
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