Labeling of a food, drug, device, cosmetic, or tobacco product is deemed to be misleading if it fails to reveal material facts.
Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.
If the label does not include the required domestic address or phone number through which the responsible person (manufacturer,
packer, distributor, or retailer identified on the drug label) may receive a report of a serious adverse event associated with the use of the drug product, it is misbranded.
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We expect you to provide the following with your payment:
- Full company name, complete physical address (street, city, state, postal code, country) of the Manufacturer, Exporter and Importer
- Company DUNS Number
- Telephone and email of the Exporter and Importer
- FDA Registration Number of the Manufacturer, Exporter and Importer
- Products labels