Service Description:
– Regulatory Review per Title 21, Food and Drugs Chapter I, FDA Department of Health and
Human Services, Subchapter E, Animal Drugs, Feeds, and Related Products Section 512 of the
FD&C Act.
Requirements:
– 3 Panel Label Image in .pdf format. Email to services@consultareinc.com
Deliverables:
– Label Review Report (Product Name, Manufactured By, Standards, Purpose, Introduction,
Definition, Requirements, Reference Images, Conforming or Non-Conforming Status,
Observations, and Recommendations.)
– Product Review (Principal Display Panel, Label Artwork, Designation of Ingredients, Use of
common or usual name, Name and place of business of manufacturer, packer, or distributor,
Country of Origin, Highlighting Allergen, Suggested Use, Storage Instructions, Warning/Caution,
Disclaimer, Supplemental/Nutritional labeling, UPC/Barcode, Lot Number, Claims.)
Delivery Date:
– 5 Business Days upon receipt of the completed information required for inputs.
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