Post Inspection Regulatory Action by US FDA - 21 CFR 803 - MDR Reporting

E

Ethan Loh

#1
Hi everybody,

I would like to ask what sort of regulatory action/s will US FDA take after they inspected a site and found it to be in a non-compliance state (especially with regard to 21 CFR 803 - MDR reporting).

It all started with a FDA Form 483,....... (what next)?


Please advice.
 
Elsmar Forum Sponsor

Sam Lazzara

Trusted Information Resource
#2
After issuing a FDA-483 List of Observations the FDA most commonly prefers to gain compliance through voluntary actions taken by the firm. After issuance of a 483, FDA may:
- Review the firm's response and choose to take no further action
- Issue a warning letter (administrative action)
- Issue an injunction forbidding you distribute the subject devices (legal action)
- Perform seizure of the subject devices (legal action)

FDA prefers to gain voluntary compliance by issuance of only a 483, or perhaps by issuance of a Warning Letter in addition to the 483. The firm's response(s) are in many cases sufficient to prevent further (legal) actions.

The info provided on this link should help:
http://en.wikipedia.org/wiki/FDA_Warning_Letter

Sam
 
M

MIREGMGR

#4
My understanding is that FDA actions in regard to MDR noncompliance depend on the nature of the noncompliance...i.e. if reports were not submitted in proper form for minor reportable events, and if the FDA accepts that an error or a faulty system was responsible, that's important but not critical.

If on the other hand a report was not properly submitted for a patient death or serious injury, especially if the FDA thinks that the device may be causative, the risk of a repeated event may be significant and the report may have been intentionally not submitted, the FDA is likely to regard the matter as critical and to respond accordingly.
 
E

Ethan Loh

#5
Hi, thanks :) for the reply guys.

The issue my company is facing now is that we got an untitled letter from US FDA saying our corrective action is inadequate and there is no preventive action.

However, from the website of CDRH, the action indicated as "warning letter". But we only received an untitled letter.

Do anybody had any similar experience?
 
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