I definitely agree with the posts above, the design control in particular that should be reevaluated should be the verification/validation aspect of this product. Risk analysis should be conducted as well. It is important to take into consideration is that it is a homeopathic product and is not as regulated as intensely as an OTC or a prescription medication. Essentially through the Homeopathic Pharmacopoea of the United States, complaince with HPUS alone does not establish that a homeopathic medicine is safe, effective and not misbranded for its intended use. The FDA only requires for these type of products to follow GMP and labeling requirements. Finally in this particular case with the belladonna, the FDA requires a report of adverse side effects if that were to occur.

Chris