Kendal Nutricare Ltd.

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

STD NAME

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided under Section 401 of the FD&C Act and the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation.

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

NUTR DEF

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100

NUTR UNIT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10.

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).