Open Medical Device Recall: Are there consequences?

[QA-Man]

I am looking for information or articles which discuss the consequences of having a recall remain open. The "open" or "closed" status only appears when you search for the recall here: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

When we use to manually complete CFG's, I recall (no pun intended) having to declare items of a particular lot were not going to be exported but that's about all I've ever seen.

 

[shimonv]

Hi QA-Man,
Interesting inquiry...
The regulatory procedures manual, chapter 7 includes a summary of FDA responsibilities and procedures:

"Finally, FDA may take appropriate regulatory action or other measures when the firm fails to recall violative product or when a recall action fails. Regulatory actions will be taken in consultation and coordination with the district compliance branch, the appropriate center recall and compliance staffs, OEIO/DE, and when indicated, the Office of Chief Counsel, when:

1. afirmrefusestorecallorsub-recallafterbeingrequestedororderedtodosobythe FDA;
2. afirmfailstocompletearecallinatimelyfashion;or,
3. theagencyhasreasontobelievethatthefirm’srecallstrategyisnoteffective. "

Shimon