In order to gain the FDA approval the company would have to recheck their design specification document, which would state the detailed spec of the product. The company would be required to then check the amount of belladonna within the teething products to verify that the input they state is the same as the output. Since we know it is not the same they will be required to change their design input document. If you modify the DID then automatically the Design output document, DSD, design verification/ validation will all need to be updated. The FDA will scrutinize the Risk Analysis therefore, the project team will be required to update the statistical data supporting the new changes in the device so that the belladonna values will decrease. All of these edits will only be completed once a design change request is completed. The project team will have to approve of all the changes and then submit all the proper Design control forms to the manufacturers to manufacture the homeopathic teething product. Then only will the company be able to submit the proper regulation documents to the FDA for an approval process.

The design controls that could potentially be visited do include DID, DDP, DSD, verification/validation protocols, risk analysis, and risk management. However, since this is a homeopathic product, the FDA has less oversight on it than say a injectable vaccine. A homeopathic product doesn't get scrutinized in the same way by the FDA as other medical products because the product is thought to be more natural. The design control that they would have to most likely revisit would be risk analysis. From what the FDA found, the risk analysis for this product was not as thorough was it needed to be if belladonna was found in the product. That's where I believe they would have revisit so the FDA would give them approval. If they want to improve their medicine, they will need to produce their product where they can be sure there won't be any belladonna contamination.

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

Belladonna is a poisonous breed, still it has some useful in medical industry. Belladonna produces many effects in the body, including relief from spasms of the gastrointestinal tract, the bladder. This is helpful in controlling conditions such as colitis, spastic bladder, diverticulitis, infant colic, renal and peptic ulcer, and irritable bowel syndrome.
Belladonna also reduces the secretions of many organs, thereby helping to control conditions such as excessive stomach acid production. Belladonna is used to treat the rigidity, tremor, excessive salivation, and sweating caused by Parkinson's disease.Belladonna also is used to treat motion sickness, nausea, vomiting, abdominal cramping associated with menstruation, and to reduce nighttime urination.
But, there are limitations for this drug. If you see the below link you will come to know the limitations. So the application of drug with limitations must be shown by the company. Application criteria must be reviewed by the company.

The homeopathic medicine has been practiced for more than 200 years and is based on the principle where
pharmacologically-active agents are administered to treat the symptoms of a disease. Homeopathic products
come under the category of over-the-counter (OTC) or prescription medicines as compared to allopathy medicines as they are considered to be clinically safe for adults as well as children. And their potency is expressed on the product label. Usually a very few side effects have been reported with the use of these products. And they are often used along with other dietary supplements. Homeopathic products are classified as drugs under the Food, Drug,and Cosmetic Act. And the specific regulatory guidance for the marketing of homeopathic drugs is given in a U.S. FDA Compliance Policy Guide. The ingredients of the homeopathy medicines are marketed for sale in the United States after they have been reviewed for their efficacy, toxicology, adverse effects, and clinical use by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). But compliance with the HPCUS alone does not establish the fact that a homeopathic medicine is safe, effective and not misbranded. The key aspects of drug regulation for homeopathic drugs are as follows: FDCA is the Governing law, Premarket approval comprises of obtaininga HPCUS monograph, GMP, Labeling under FDA Compliance Policy Guide, Advertising under nonprescription: FTC; Prescription: FDA and the indication on labeling. So in order to get a FDA approval, the Hyland’s homeopathic teething product has to revisit all of the above mentioned key aspects.