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Posted July 17, 2023

Seller of Ashwagandha, Lion’s Mane & Other Supplements Warned for Manufacturing Violations

On March 17, 2023, the FDA issued a warning letter to Brand Packaging Group, Inc. after FDA inspection of the company’s facility found products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP).

Violations noted in the FDA’s warning letter include failure to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, failure to establish and follow laboratory control processes, and failure to test or examine the identity of any component that is a dietary ingredient, including dietary ingredients such as Organic Chaga Mushroom Extra, Echinacea Purpurea, Elderberry Fruit Extract, and Zinc. Additionally, the company’s quality control personnel failed to reject dietary supplements, such as Ashwagandha Powder, that failed to meet established specifications.

The company has previously received a warning letter indicating noncompliance with current Good Manufacturing Practices.

Brand Packaging Group, Inc. must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information and tests of related products, see ConsumerLab’s Reviews of Ashwagandha Supplements, Lion’s Mane and Chaga Supplements, Echinacea Supplements, Elderberry Supplements, and Zinc Supplements Supplements and Lozenges.

For more information, use the link below.

Warning: Brand Packaging Group, Inc.

See related recalls and warnings:

FDA Finds Problems at 52% of Supplement Manufacturing Sites in U.S. and 42% Abroad

Elite One Source Nutritional Services Warned for Manufacturing, Labeling Violations

NutraCaps Labs Warned for Unsafe Ingredients and Manufacturing Violations

Seller of Digestion Supplements Warned for Manufacturing Violations

Seller of CoQ10, Resveratrol and More Warned for Manufacturing Violations