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U.S. Department of Health and Human Services

Import Alert 53-12
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 53-12
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Black Hair Cream From The Dominican Republic"

Reason for Alert:
During the past seven months San Juan District has detained and refused admission several shipments, from different shippers, of "Black Cream For Hair" imported from the Dominican Republic. FDA laboratory analyses revealed the product to contain an undeclared, unidentified, and non-certified black color. The product is manufactured by Laboratorios Keys, C por A R.I. 12618, Dominican Republic for Star Products, S.A., Trinitaria No. 1, Santo Domingo, Dominican Republic.

Guidance:
Districtsa may detain, without physical examination, all shipments of Bano De Crema Negra Para El Cabello Black Cream For Hair) manufactured by Laboratorios Keys, C por A R.I.12618, Dominican Republic for Star Products, S.A., Trinitaria No. 1, Santo Domingo, Dominican Republic.

Analytical Methods: See AOAC official Methods of Analysis 15th Edition (1990, Chapter 46, pgs. 1115-1136.)

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:
BANO DE CREMA NEGRA PARA EL CABELLO (BLACK CREAM FOR HAIR)

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 706(a) [Adulteration, Section 601(e)]."

OASIS charge code - COSM COLOR

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


DOMINICAN REPUBLIC
Laboratorios Key C Por A
Date Published : 09/18/2009

Calle Central No. 3 , Zona Industrial de Herrera , Santo Domingo, DOMINICAN REPUBLIC
53 E C - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 09/18/2009

Desc:Bano De Crema Negra Para El Cabello (black cream for hair)
Notes:unidentified non-permitted black color
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN REMARKS);
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Black Star black cream for hair
Notes:Bano De Crema Negra Para El Cabello; unidentified non-permitted black color
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN REMARKS);

Star Products SA
Date Published : 09/18/2009

Trinitaria No 1 , Santo Domingo, DOMINICAN REPUBLIC

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