FDA Import compliance

[pokeyoldgram]

Regulatory Procedures Manual March 2009 Chapter 9 Coverage of Personal Importations

This link may help to explain some of the seemingly conflicting actions/information (that may or may not be true) by the FDA.

In this chapter you will find info on personal use shipments of medical devices or drugs.
When descretion can be used in stopping shipments.
If you are not brain fried by then...try some of the other manuals on complaince, its quite informative, however there is a disclaimer that while this is the SOP its not binding to the public or the FDA.

 

[MaxxVapor]

Interesting read. Thanks.

 

[taz3cat]

Regulatory Procedures Manual March 2009 Chapter 9 Coverage of Personal Importations

This link may help to explain some of the seemingly conflicting actions/information (that may or may not be true) by the FDA.

In this chapter you will find info on personal use shipments of medical devices or drugs.
When descretion can be used in stopping shipments.
If you are not brain fried by then...try some of the other manuals on complaince, its quite informative, however there is a disclaimer that while this is the SOP its not binding to the public or the FDA.

I guess I can keep ordering as long as I don't order a big supply. The way I read it , the suppliers are the ones going to have a problem, because they have to order so much to get it wholesale.

I hope this get straighen out for our US suppliers.

 

[Reverend Damien Caine]

Heh.... define big supply. I had 30+ starters and a slew of parts make it through this week.

 

[stevejo]

Heh.... define big supply. I had 30+ starters and a slew of parts make it through this week.

Most vendors that I have dealt with require MOQ's in the 100-unit neighborhood for their wholesale pricing. Most.

 

[Kamanjah]

I searched Import Alerts on the FDA site and found none for our toys. Maybe good news!