Dietary supplement good manufacturing practices violations identified at 10 foreign facilities in 2015 are included in FDA’s latest import alert to block products from entering the US.

One firm was listed on FDA’s import alert due to supplement GMP problems at the end of 2014, but in 2015 more firms “have been demonstrated to be non-compliant with the GMPs to the point that we want to prevent the products from entering the US market,” according to the agency.

The holdover from 2014, Herbolaris Internacional Ltd., has been on import alert for shipments from its plant in Zapopan, Jalisco, Mexico, to be detained without physical examination since December.

FDA’s most recent update to its GMP-linked DWPE import alert for supplement products includes firms found to be non-compliant as recently as Aug. 19. Facilities operated by five other firms in Mexico, two in India and one in Sweden also are on the list (see table below).

According to FDA’s warning letter database, the agency has submitted 11 warnings in 2015 to supplement firms for GMP violations; many more warnings have noted other violations including non-compliant claims and ingredients.

The number of domestic firm warnings reached 11 in 2011, the first year after FDA’s 2007 final rule for supplement GMPs became effective for all firms, increased to 30 in both 2012 and 2013 and was at 26 in 2014, according to the warning letter database.

While domestic supplement manufacturers and marketers generally continue distributing products after FDA finds GMP problems at their facilities, foreign firms’ products are stopped at ports of entry into the US after the “Red List” section of an import alert includes their names.

“FDA will add a company and its respective dietary supplement product to the Red List for this import alert after FDA performs foreign inspection of the dietary supplement manufacturers and determines that the company is not operating in conformity with current dietary supplement good manufacturing practices,” CFSAN officials said in an email.

They also noted that other foreign firms found to have GMP problems could have received a warning letter but are not on the import alert. “This differentiation is based on the level of concern with their GMP system.”

And like domestic businesses, a foreign firm can satisfy FDA’s concerns from a GMP inspection by correcting the problems in response to a form 483 from the agency.

FDA established its import alert category for firms noncompliant with supplement GMPs in November 2011, more than a year after the final rule for the regulations became effective for all firms.

Import Alert DWPE For GMP Problems
FDA on Aug. 19 published this list of firms with dietary supplement products subject to detention without physical examination after an agency inspection found serious deviations of good manufacturing practices.
Importer Name, Date of Finding	Importer Headquarters
Dabur India Ltd., 04/06/2015	Alwar, Rajasthan, India
Patanjali Ayurved, 04/06/2015	Haridwar, Uttarakhand, India
Armonia En Envasado Y Nutricion SA de CV, 03/06/2015	Tlaquepaque, Jalisco Mexico
Healthy People Labs S de RL de CV, 08/19/2015	Colonia Los Hoyos , Irapuato, Mexico
Herbolaris Internacional, 12/17/2014	Zapopan, Jalisco, Mexico
Laboratorio Mas Natural S. de R.L. de CV, 06/17/2015	Colonia Serrano , Irapuato, Mexico
Mas Natural Salud Y Bienestar, 06/17/2015	Irapuato, Guanajuato, Mexico
Mas Natural Salud y Bienestar, S. de R.L. de CV, 06/17/201	Irapuato, Guanajuato, Mexico
Natural Health II SA de CV, 07/16/2015	Irapuato, Guanajuato, Mexico
Natural Health II SA de CV, 07/16/2015	Irapuato, Guanajuato, Mexico
TwoPac AB, 05/29/2015	Eslov, Malmohus Lan, Sweden

Foreign Firms’ Supplement GMP Problems Rival US Warnings

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