Import Alert # 54-14 Published Date: 05/29/2015 Type: DWPE Import Alert Name: DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT

SWEDEN

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TwoPac AB

Date Published : 05/29/2015

Vindelvagen 3 , Esl�v, Malm�hus L�n SWEDEN

40 Y - - 99 Baby and Junior Food N.E.C.

Date Published: 05/29/2015

Desc:BioGaia ProTectis Baby with vitamin D Probiotic Supplement
Notes:An FDA inspection of the firm found serious violations of FDA?s cGMPs for dietary supplements (21 CFR Part 111).

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners

Date Published: 05/29/2015

Desc:BioGaia ProTectis Baby with vitamin D Probiotic Supplement
Notes:An FDA inspection of the firm found serious violations of FDA?s cGMPs for dietary supplements (21 CFR Part 111).

54 A - - 14 Vit D

Date Published: 05/29/2015

Desc:BioGaia ProTectis Baby with vitamin D Probiotic Supplement
Notes:An FDA inspection of the firm found serious violations of FDA?s cGMPs for dietary supplements (21 CFR Part 111).

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.

Date Published: 05/29/2015

Desc:BioGaia ProTectis Baby with vitamin D Probiotic Supplement
Notes:An FDA inspection of the firm found serious violations of FDA?s cGMPs for dietary supplements (21 CFR Part 111).

66 Y - - 99 Exhibits - Other Drug Related Items N.E.C.

Date Published: 05/29/2015

Desc:BioGaia ProTectis Baby with vitamin D Probiotic Supplement
Notes:An FDA inspection of the firm found serious violations of FDA?s cGMPs for dietary supplements (21 CFR Part 111).