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GMP Problems Stop Canadian Firms’ Topical OTC, Homeopathic Imports

Executive Summary

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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Promotional Lip Balm, Sanitizer Imports Blocked On Drug GMP Problems

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Promotional Lip Balm, Sanitizer Imports Blocked On Drug GMP Problems

In addition to AZX Sport lip balms and hand sanitizers, other topical consumer drugs often considered personal care or cosmetic products outside the US were added in the latest update to FDA's list of import alerts for "detention without physical examination of drugs from firms which have not met drug GMPs."

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