Les Importations Herbasanté Inc.
FDA issued a warning letter to Les Importations Herbasanté Inc., a Canadian contract manufacturer of homeopathic drug products (including pediatric formulations), following an August 2023 inspection that revealed significant CGMP violations. The firm failed to perform adequate identity testing of high-risk components such as glycerin (which carries risk of lethal diethylene glycol/ethylene glycol contamination), failed to validate its manufacturing processes, and had an inadequate quality control unit. As a result, FDA placed the firm on Import Alert 66-40, making its products subject to detention or refusal of admission into the United States, and required corrective action within 15 working days.
Required actions (5)
FDA placed your firm on Import Alert 66-40 on January 26, 2024.
shipments of articles manufactured at Les Importations Herbasanté, Inc., at 377 Sainte-Croix Ave., Saint-Laurent into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of your drug products.
you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market.
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