Customer Complaint Trigger Point for FDA

[keithm696]

Hi All,
I'm the QA Manager for a sheltered workshop in Missouri that builds first aid kits. We deal with OTC type meds as part of the components in various configurations of these kits and I'm trying to locate a sample flow chart or check list recall process. I had a visit from FDA last summer and have been trying to fix the few findings that we had. Recall is real even in the OTC arena. Any guidance or help would be appreciated.
Regards,
Keith

[Al Rosen]

Originally Posted by keithm696

Hi All,
I'm the QA Manager for a sheltered workshop in Missouri that builds first aid kits. We deal with OTC type meds as part of the components in various configurations of these kits and I'm trying to locate a sample flow chart or check list recall process. I had a visit from FDA last summer and have been trying to fix the few findings that we had. Recall is real even in the OTC arena. Any guidance or help would be appreciated.
Regards,
Keith

Hi Keith:

I would you review the regulations 21 CFR 803, 806 and 810. If you don't have a copy, you can access them at
http://www.access.gpo.gov/nara/cfr/c...le-search.html

Investigate each complaint and categorize them according to seriousness. The ones that might be a risk to health, cause serious injury or death require attention in accordance with the regulations I cited.

You can find some good resources at
http://www.clinivation.com/pages/res.../downloads.htm

If you have specific questions, I will offer my opinion for FWIW since you best know your business and to quote Marc, One size does NOT fit all!

[keithm696]

Al,
The site was very informative and I have a few ideas to brain storm with staff.
Thanks very much,
Keith