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Tina
Tina, Lawyer
Category: Legal
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Experience:  JD, BBA Over 25 years legal and business experience.
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Are there FDA GMPS associated with manufacturing a spore

Customer Question

Are there FDA GMPS associated with manufacturing a spore containing finished dietary supplement?
Submitted: 7 months ago.
Category: Legal
Expert:  Briarcliff767 replied 7 months ago.

HI My name is ***** ***** I am happy to assist. I am sorry that you have not received an ansswr. I would be happy to help. Can you please let me know more about what you are needing to know. Thanks Hope

Customer: replied 7 months ago.

I am not sure what additional information is needed. Spore containing organism are very difficult to remove from manufacturing equipment and the FDA knows this..I am asking if there is a FDA guidance regarding clening procedures and detection methods to determine if the cleaning has effectively removed the spore