On June 15, 2023, the FDA issued a Warning Letter to Healthex Distributors, Inc. following an inspection of the company’s manufacturing facility, which found the company’s products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). Violations noted by the FDA include failure to establish and follow written procedures for responsibilities of quality control, failure to establish and follow written procedures for holding and distributing operations, and failure to identify who is responsible for quality control operations.

Additionally, Dr. Santa Cod Liver Oil and Dr. Santa Orange Blossom Flower Water products were found to be misbranded for violations such as failure to declare common names of ingredients on product labels, failure to include all labeling information in all languages represented on product labels, failure to include a domestic address or phone number in case of serious adverse events, and more.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

See ConsumerLab’s Review of Vitamin A Supplements for tests of cod liver oil and related products.

For more information, use the link below.

Warning: Healthex Distributors, Inc.

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