Learnaboutgmp Community

Recall Situation

Hi folks

I would really appreciate if any of ye have any Guidance documents on how to manage a Recall situation and if there is Guidance on the Limits of Rework? I’m not even sure if such Guidance exists but if it does and ye know where to direct me to source it I would really Appreciate it.

Thanking you in advance for your continued support on my constant bombardment of seeking Regulatory Info.

Regards

21 CFR part 7 and
refer to the below mentioned site
http://www.cfsan.fda.gov/~lrd/recall2.html

think this will give you an idea of the recall strategy and there is a recall assessment
rgds,
kalyan

The relevant MEDDEV

(
http://ec.europa.eu/enterprise/medical_devices/meddev/
)

has just been updated, make sure you implement all key elements into your

procedures.

To test the effectiveness of your recall procedures (and to provide evidence

of implementation) I tend to recommend that companies perform a mock

recall every now and again.