FDA - Audit - Response - Observation form 483. Do we now receive a formal letter?

[Eveline]

We had a FDA inspection and the auditor gave us a observation form 384. Do we now receive a formal letter from the FDA with instructions or conclusions??

Or do we have to answer upon the already received form? Are there any deadlines?

Thanks
Eveline

[Al Rosen]

Originally Posted by Eveline

We had a FDA inspection and the auditor gave us a observation form 384. Do we now receive a formal letter from the FDA with instructions or conclusions??

Or do we have to answer upon the already received form? Are there any deadlines?

Thanks
Eveline

Respond immediately, do not wait for a letter.
Look at What to do once an FDA Inspection is over - Seeking FDA site Link

and

Rate your FDA Audit Experience
for some discussion on this subject.

[Weiner Dog]

Just because one receives an FDA 483, this does not mean that one gets a warning letter. Basically, one situation I condition (as noted in compliance program 7382.845) warrants a warning letter (i.e. OAI); whereas only situation II conditions do not warrant a warning letter, but a VAI letter. The other option is NAI (i.e. no noted deviations or minor deviations not placed on a FDA 483), where no FDA 483 is issued. Also, warning letters can also be issued even if no 483 observations are noted (such as pertaining to unapproved labeling claims, including those noted on a company website).

Whether it is NAI, VAI, or OAI, a letter will be sent by FDA. The warning letter notes a timeframe to reply to FDA, but the other letters (VAI or NAI) do not. In either case (OAI or VAI), within a few days to a week of the FDA inspection, send a reply to FDA (even if it says that you are working on correcting all deviations and additional correspondence will follow). Give a timetable and remember to include proof that the deviations have been corrected (such as copies of revised written procedures or CAPA's).

[Al Rosen]

Would you explain what OAI, NAI and VAI means.

[Weiner Dog]

Originally Posted by Al Rosen

Would you explain what OAI, NAI and VAI means.

The terms OAI, VAI, or NAI refer to a FDA classification system as to how FDA inspections or noted findings (such misbranding from examination of a firm's website) are classified (depending upon the severity/risk of the findings), where:

OAI= Official Action Indicated. (Major 483 items or mislabeling/misbranding)
VAI= Voluntary Action Indicated. (Other 483 items or mislabeling/misbranding)
NAI= No Action Indicated.

Examples of MEDICAL DEVICE OAI deviations include: total failure of system areas (such as lack of a management controls or CAPA system), failure of major QSR areas (such as failure to validate a sterilization operation), lack of an MDR procedure, failure to submit a death or serious injury MDR MedWatch report to FDA, or failure to conduct audits of device tracking system.

Other examples are noted in the C/P 7382.845.

http://www.fda.gov/cdrh/comp/guidanc...dfversion.html

[Ajit Basrur]

Refer this post also