During an inspection conducted on September 6, 2024, the Food and Drug Administration issued 11 citations to Perez Lab, Inc. in Miami concerning food composition, standards, labeling, and economic compliance, 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 calibrate instruments or controls used in manufacturing or testing a component or dietary supplement at the frequency specified in writing by the manufacturer or at routine intervals or as necessary to ensure the accuracy and precision of the instruments or controls.’
- ‘You did not make and keep records associated with your equipment and utensils operations.’
- ‘For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.’
- ‘You did not establish label and packaging specifications.’
- ‘You did not establish product specifications for identity, purity, strength, composition and limits on contamination.’
- ‘You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.’
- ‘You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement.’
- ‘Your component, packaging, labeling and products received for packaging or labeling as a dietary supplement records did not contain the required documentation.’
- ‘You did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.’
- ‘Your master manufacturing record did not include all required information.’
- ‘Your batch production record did not include all required information.’
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.
