Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
This is a 25% decrease from the number of companies cited in the previous year.
Of the 18 citations issued, the most common citation was 'You did not implement quality control operations to ensure the quality of the dietary supplement'.
All of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, three should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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.
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 quality, according to its website.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Grandma's Herbs, Inc. | Food and Cosmetics | 02/15/2023 | Quality control - quality, dietary supplement |
Grandma's Herbs, Inc. | Food and Cosmetics | 02/15/2023 | Specifications - labels, packaging |
Grandma's Herbs, Inc. | Food and Cosmetics | 02/15/2023 | Specifications - product received for packaging, labeling |
Grandma's Herbs, Inc. | Food and Cosmetics | 02/15/2023 | Packaging, labels - quarantine |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Specifications-component purity, strength, composition |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Specifications met - contamination limits |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Component - verify identity, dietary ingredient |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Component - qualify supplier |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Specifications met - verify; finished batch |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Master manufacturing record - controls, procedures |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Batch record - complete |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Sanitation monitoring |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Corrective action - predetermined plan |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | Calibration, testing - no records |
InnoMark, Inc. | Food and Cosmetics | 03/15/2023 | HACCP plan - not validated |
Prolifix Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Quality control - quality, dietary supplement |
Prolifix Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Specifications-component purity, strength, composition |
Prolifix Nutrition, LLC | Food and Cosmetics | 08/25/2023 | Specifications - identity, purity, strength, composition |