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Posts posted by mallen5usa
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FDA does not license, and does not regulate recovered plasma. It is considered a manufacturing by-product (that's why you can't find it in the reg). Do you know what your purchaser is going to do with it? My guess is they will either re-sell it to a plasma fractionator, or they are using it for research.
You can hook up with ABC and look into group selling to fractionators. You will need to comply with OZ(Aus) or EU standards to qualify, but you would probably realize a better price point by doing so.
m
FDA Inspector
in Accrediting Agencies
Posted
Did the inspector issue a Form 482 (Notice of Inspection)? If not, then you weren't really "inspected". They do have the authority to walk into any place dealing with regulated products, but not necessarily to inspect. Since there was a specific request for performance reviews, and the odd ball question about exterminators, they may have been following up on a "whistle blower" type report that had to do with a related situation?
m