New US FDA regulations for Bath & Body

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The good manufacturing process thing is the only part that would include inspections and that's section 606, which does not apply to small businesses . We're not facilities under that. No registration , no GMP enforcement .

In fact a text search for the word inspection only comes up with records inspection if a product is found to be adulterated , or upon causing a serious adverse health event (i.e., if someone dies or is hospitalized or the like, from your product). Which seems right & proper, and also vanishingly rare.
My reading was that they could conduct inspections related to adverse events, but maybe I'm assuming too much there?
 
My reading was that they could conduct inspections related to adverse events, but maybe I'm assuming too much there?
All I see is *records* inspections. And remember, a serious adverse event is a big hairy injury, or death; not something I've ever heard of a small crafter's product ever causing.

If you're (general you) making a product that can cause death or hospitalization, you're not making a product I've ever heard of a US home crafter selling to the public and a site inspection would be the least of your worries.
Capture+_2023-03-28-13-03-54_1adverse.png
 
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An infection I could see happening from an ill preserved lotion, but am not aware of the FDA having had to intervene in such a case. It may have happened , don't know.
 
But those are all good questions to ask; the more clarity, the better; the COHE (Coalition of Handcrafted Entrepreneurs) and Marie Gale seem like places to start.
 
It says facilities are subject to inspections. So how can small businesses not be facilities but still be subject to inspections? I'm confused. The labeling is a whatever kind of thing, it just makes the font size smaller. Also, I thought small businesses are exempt from registration, so how would they know to inspect us?
 
It says facilities are subject to inspections. So how can small businesses not be facilities but still be subject to inspections? I'm confused. The labeling is a whatever kind of thing, it just makes the font size smaller. Also, I thought small businesses are exempt from registration, so how would they know to inspect us?
We're not subject to inspections. Nor registration . Unless you make over a million a year or whatever that astronomic level is.

If one injures someone in an adverse event, their *RECORDS* are subject to inspections .

The facilities inspections mentioned in this law (which covers enormously more than cosmetics) are for drug making facilities.. overseas ones.
 
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