GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports
This article was originally published in The Pink Sheet
Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.
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The June 2 update to FDA's list of businesses and their products banned from import also increases the number of Canadian firms identified during 2017 as shipping supplement products that make drug claims or that were made in facilities out of compliance with the agency's good manufacturing practices regulations.
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