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.