During an inspection on July 17, 2024, the Food and Drug Administration (FDA) identified eight violations concerning foodborne biological hazards at Alfa Vitamins Laboratories, Inc. in Miami, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘You did not identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces.’
- ‘Your hand-washing facilities are not adequate and do not furnish running water at a suitable temperature.’
- ‘You did not establish component specifications for strength and composition.’
- ‘You did not establish product specifications for the strength and composition of the finished dietary supplement.’
- ‘You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.’
- ‘Your master manufacturing record did not include a representative label, or a cross-reference to the physical location of the actual or representative label.’
- ‘You did not follow written procedures for laboratory operations.’
- ‘You did not hold components and dietary supplements under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
