Recalls & Warnings
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Posted January 12, 2021
Infuscience, Inc. Warned for Unsanitary Production Practices
On December 21, 2020, the FDA issued a warning letter to Infuscience, Inc. dba Bioscrip Infusion Services following a facility inspection in July, 2019 which found the company's products to be drugs, and therefore, adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.
These violations include preparing products that were intended or expected to be sterile under unsanitary conditions as required by federal regulations. Employees failed to disinfect and change gloves to prevent contamination, the company did not perform adequate air ventilation studies, drugs were produced without cleaning work surfaces and instruments, and certain surfaces were visibly dirty, among other sanitary violations.
Infuscience, Inc. dba Bioscrip Infusion Services must amend their production practices and inform the FDA within 15 days of the specific steps they are taking to fix these violations.
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